Devens Job Description Sample
Lead Software System Design Engineer
As a Lead System Design for the cloud-based Motion Analyzer software, you will act as a technical leader for your product through every aspect of its journey. From vision to execution, technical roadmap definition, supporting the product manager with feature prioritization and directing the development teams, you shape the future of the tool and help it grow a loyal internal and external customer base. In this role you will work with a cross-functional team that includes product marketing, sales, product development and engineering as well as partner companies.
Rockwell Automation is looking for an experienced system design lead who's passionate about helping our customers size optimal motion and drive solutions and design better machines. Ideally, you have a strong experience with industrial automation machine design, motion control, software development and a keen acumen for new technologies and market trends.
Lead design and architecture of cloud-based applications with thousands of users in collaboration with third party software vendors
Define technical product roadmaps with input from Product Manager and other Subject Mater Experts
Lead software development efforts for the tool and direct/prioritize daily work of 3rd party team of software developers in collaboration with assigned Project Manager
Assist in code base maintenance and database optimization
Design, implement and optimize sizing algorithms for Motion applications
Collaborate with other engineering teams (CE's, System Architects, etc.) to model new control algorithms and validate them for accuracy
Model thermal characteristics of motors and gearboxes
Define product features and sign off on developments efforts
Lead technical validation of software features for accuracy and effectiveness
Resolve technical support escalations (3rd level after Tech Support and CE support)
Assist in writing tech notes and KnowedgeBase articles
Support all aspects of product lifecycle from strategic planning to tactical activities (feature definition to launch and support)
Translate marketing requirements to detailed technical feature definitions.
Ensure projects are completed on time, within budget and according to quality standards.
Work closely with UX and user research groups to optimize user centric product features and workflows.
Be the key technical liaison for partner companies to drive greater adoption.
Be able to travel up to 20% of the time globally.
Be a strong leader within a cross-functional team, developing the right product and features to fill market needs, and serve as the customer advocate interacting with functional partners including Engineering, software development partners, Program Management, Market Development, Finance, Quality and Legal.
Make appropriate & timely decisions based on current information and ensure adherence to existing company policy relating to delegation of authority.
Lead development and implementation of technical product roadmaps and improvements
Conduct tasks in accordance with applicable health, safety, quality, and environmental regulations (state/federal laws, ISO9001, ISO14000, etc.) as well as Rockwell Automation policies and procedures.
Display dedication and concern toward completing work correctly, thoroughly and in an appropriately timely manner.
Be very open with management and peers, and conscious of keeping other members of the team up to date on status of work.
Communicate timely and regularly with project teams to ensure that they have all of the information required to successfully implement projects.
Interface and provide direct input with other RA product groups such that the corporate business goals are aligned.
Interface appropriately with vendors and partners to ensure features and requirements are implemented in a timely and responsible manner.
EOE, M/F/Disable, Vet
Director, Independent Cart Technology
Responsible for managing overall independent cart and linear business. This includes achieving orders, shipments, revenue, market share, and margin goals, as well as the identification and direction of new product requirements.
Manage productivity and drive OROS to motion goals. Operates as a catalyst and architect for the business strategy.
Establish a concise product/market direction and implementation plan, which is communicated to the marketing group, sales organization, channel, and customer.Responsible for analysis and determination of total market potential and establishment of implementation of marketing strategies to optimize short and long range business performance in terms of profitability, sales and market penetration.Responsible for establishing product and market objectives to meet existing and anticipated customer requirements including product definition, cost and availability. Ensure all new product introductions are properly supported with product promotions, sales literature, stocking programs and appropriate training tools.Provide market surveys and analysis to guide product specifications in new product lines to provide direction for sales activities.Ensure the generation and implementation of annual operating plans and budgeted expenses to support the long term business strategies and monitor performance by product line.Generate and maintain on-going sales forecasts by product line and projected commercial expenses to enable the continuous maintenance of manufacturing build plans.
Possess strong execution skills, process improvement focus and overall accountability for results.
Possess strong leadership and interpersonal skills combined with technical capabilities and market/business knowledge to create a customer focused vision for the future.
Provide leadership in planning product obsolescence, as required, as part of on going product strategies to maximize effective use of manufacturing resources in providing the required product portfolio.
Coordinate with strategic business partners in order to achieve objectives
Responsible for effective market communication to both customers and distributors including product promotion, technical literature, trade show participation and other relevant media.
Define and communicate market and customer requirements through interaction with project teams, business teams, and other departments to maximize market success.
Be accountable for maintaining appropriate level of communication with Vice President, peers, commercial and operations organizations.
Determine the total market (domestic and international) for the product line and meet share objectives.
Generate and maintain five-year strategic plans, documenting strategies, utilization of resources, impact on business results, and implementation of action plans required to achieve worldwide product/market development goals
Monitor market economics and business performance to make recommendations and implementation plans for pricing strategies and channel access, maximizing profitability.
Proactively seek out and implement product cost reductions, quality enhancements and productivity improvement as part of the product strategies.
Ensures thorough familiarity with company policies and procedures. Appropriately applies policies and procedures in compliance with government laws.
Policies and procedures include, but not limited to: Standards of Business Conduct, Intellectual Property, Control Environment, Information Protection, ISO 9000 & 14000, government regulations (e.g. health, safety, quality and environmental), and functional policies published on the Rockwell Automation Information Network.
For those with supervisory responsibilities: Trains and motivates subordinates in the importance of full compliance with the letter and spirit of such policies and procedures.
EOE, M/F/Disabled, Vet
Expressive Arts Coordinator
Provide direct support to individuals served including providing assistance in personal care activities. Perform the required training and documentation necessary for group and individual participant goal achievement. Develop and implement expressive arts curricula.
To act as Case Manager for individuals including case record maintenance, as assigned by the Program Manager in relation to Activities curricula.
To work directly with program participants and their significant team members in the development and follow up of Day Habilitation Support Plan (DHSP), including attendance at case conferences.
To participate in program and/or agency committees as assigned. To work with each individual's needs as they relate to their home, work and community environments, including meeting with parents, guardians, residential providers and other outside agency personnel for progress reports. To develop and implement Activities/expressive arts curricula including documentation of such, for program participants and provide support for the delivery of said curricula.
To develop and maintain inventory of Activities/expressive arts curricula materials and equipment and make recommendations to the Program Manager for purchasing of appropriate materials. To design and implement instructional units on both an individual and group basis to meet each individual's needs and interests. To participate in activities as a member of the Interdisciplinary Team as assigned.
Provide assistance as needed for program participants' personal care needs including dining, toileting and transfers. To transport participants as assigned. To be familiar with the agency's overall operation as established by written description of service and organizational information. Be familiar with, and assist in the implementation of, the Seven Hills Foundation Policies & Procedures, the site's Program Specific Policies & Procedures and the regulations governing the program.
B.A. degree in Education or related field and one (1) year experience in an activities related field. Alternative qualifications: High School diploma and two (2) years experience working in an activities related position serving individuals with intellectual or developmental disabilities.
Previous expressive arts teaching experience preferred. Valid driver's license required.
The Associate Scientist will be responsible supporting downstream process development of recombinant protein therapeutics. This role will support process development, process characterization, scale-up and technology transfer.
The successful candidate will be highly proficient in performing chromatography, filtration unit operations as well as conducting necessary analytical assays. In order to be successful in a highly dynamic environment, the candidate should be a highly motivated self-starter with excellent interpersonal, communication and organizational skills.
Design and develop purification processes for recombinant protein therapeutics.
Conduct experiments, organize and summarize data.
Perform virus clearance evaluation of downstream processes.
Perform / oversee process characterization of downstream unit operations.
Work closely in collaboration with other Process Development Functional Areas.
Author and review technical documents and protocols; follow written scientific methods and experimental protocols, documents results, authors and reviews summary reports.
Support manufacturing and scale up laboratory activities as required
A degree in Chemical Engineering, Chemistry, Biology or a related discipline.
Minimum bachelor's degree with 3 to 5 years relevant experience; Masters preferred.
Highly proficient with operation, maintenance, etc. of downstream laboratory equipment. In particular expertise with automated chromatography workstations such as AKTA Avant, etc. is highly desirable.
General experience with purification unit operations such as chromatography (various modes), tangential and normal flow filtration, etc.
Hands on experience with UV/Vis spectroscopy, HPLC and other analytical techniques is highly desirable.
Basic understanding of downstream process development activities.
Development experience for both early- and late-stage molecules is highly desired.
Excellent organizational skills and highly Methodical.
Excellent communication and interpersonal skills.
Work independently and collaborate with other groups. Deliver results in line with project and team objectives.
Manager, Quality Systems & Compliance
To maintain Internal Compliance activities at the Devens site. This includes program ownership of self-inspection, change control and site compliance with BMS corporate policies and directives (P&D) as well as management of Health Authority requests.
Owns the self-inspection (i.e. internal audit) program at the site - including management of procedures, development of risk-based inspection schedule, execution of inspections and management of response development and remediation.
Track commitments to completion and trends themes accordingly.
Owns the site change control program - including management of procedures, oversight of key performance indicators for high quality changes and on-time delivery.
Owns the Annual Product Quality Review (APQR) program at the site – including coordination of individual sections for APQR reports (Manufacturing, testing, quality systems, etc.).
Ensures site compliance with BMS corporate policies and directives.
Documents impact assessments and track commitments to completion.
Escalates site compliance issues accordingly. Participates as a core team member in any corporate or regulatory agency inspections and lead cross functional teams to develop responses, tracking the commitments to completion.
Maintains Site Master File and serves as key point of contact (POC) with CMC Regulatory group to respond to pre- and post-filing requests for site based information, includes extensive communication and coordination to fill a variety of requests.
Leads site inspection readiness activities by conducting readiness assessments against the relevant HA requirements, benchmarking with prior network and industry experience, and maintaining relevant training (may include mock inspections with SMEs).
Maintains the inspections logistics program including administration of audit request/near miss system.
Hires, trains, and develops qualified Quality Compliance specialist and ensures personnel has adequate training, education and experience to perform their GMP related job function effectively.
Maintains resource model for core responsibilities.
Knowledge and Skills:
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
A minimum of 8 years of relevant experience including 4 years of GMP Quality experience.
Prior management experience obtained by direct or matrix team leadership is required.
Proven experience in Health authority inspection preparation and management (backroom and front room) is required.
Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc.
Senior Associate, QC Microbiology
To perform microbiological testing on samples using defined methods in a cGMP compliant laboratory. Assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor. This position will be Sunday-Thursday.
WFI/CS collection and testing. Additionally, perform in-process testing in accordance with SOPs, safety, and cGMP guidelines to support the release and stability of finished products, raw materials, in-process materials, and various components.
2.Monitor critical operating parameters for equipment and instrumentation to ensure standard operation.
3.Recognize, report, and document deviations from test methodologies, specifications, and alert limits
4.Maintain up to date knowledge of cGMP, job related SOPs and complete all assigned training on time.
5.Coordinate sample receipt, logging, tracking, storage, distribution and
Knowledge of science generally attained through studies resulting in a B.S., in biological sciences, a related discipline, or its equivalent.
A minimum of 2 years experience in a regulated microbiology laboratory.
Excellent manual dexterity including proficiency in
Familiarity with the use of air sampling equipment, autoclaves, micro ID methods, and endotoxin testing.
Experience requiring one to work independently as well as part of a team, to complete assignments within defined time constraints.
Demonstrated ability to concurrently conduct multiple routine tasks, procedures, and operations effectively and consistently
Sr Bioprocess Lead - Downstream
The Senior Bioprocess Lead leads and drives the execution of manufacturing processes according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP's). The Bioprocess Lead is responsible for daily oversight of group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Bioprocess lead is required to guide the shift personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.
Adheres to Good Manufacturing Practices and standard operating procedures.
Oversees the use of and coordinates maintenance of production equipment and systems to support biologics production which includes either upstream or downstream unit operations (i.e. Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment, Buffer equipment, chromatography skids, membrane operations, column packing skids, etc.)
Effectively uses and possesses mastery for process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and work instructions and that training is completed on time.
Under direction of area management, leads the coordination and implementation of special projects such as validation or complex investigations.
Revises and creates process documents with no instructions, Supports routine process investigations independently.
Reviews batch documentation and for each manufacturing lot in conjunction with Quality representative. Resolves documentation and process issues. Develops CAPA as necessary to expedite lot release.
Champions areas specific initiatives associated with work safety
Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Advises Shift supervisor or manager on improvements which may optimize work processes.
Works on routine manufacturing assignments as well as assignments that are complex in nature where action and a high degree of initiative are required in resolving problems and making recommendations as required.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is desired but not required.
A minimum of 6+ years of process operations experience in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Strong knowledge of either upstream or downstream unit operation is essential.
Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Previous work experience where attention to detail and personal accountability were critical to success
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers.
Team Lead - Sample Logistics
1.Trains and mentors staff, occasionally performs sample receipt and processing of raw materials, in-process, stability, bulk drug substance (BDS) and drug product (DP) samples.
2.Performs testing on BDS and DP samples including, but not limited to appearance testing, reconstitution time and weight variation
3.Revises and writes procedures for managerial review and approval
4.Performs and/or provides subject matter expertise in root cause investigations for sample logistics.
5.Reviews/approves test data obtained for compliance to specification and reports abnormalities.
6.Leads the coordination and communication of samples to 2nd and 3rd parties as well as contract laboratories
7.Coordinates interdepartmental activities, providing technical expertise to ensure that the programs are in compliance with current industry standards.
8.Coordinates and collaborates with internal and external customers in order to support testing in Devens-QC
9.Reconciles and orders critical reagent inventory.
10. Logs in nonroutine LIMS jobs to support validation, investigation, qualification of sample
11. Participates on a variety of teams in support of business improvement projects.
12. Collaborates with management on the development and reporting of KPIs and metrics in the department
13. Drives and promotes continuous improvement projects
14. Leads the implementing OPEX initiatives the Sample Logistical area, including implementation of Lean labs Supports the implementation of Lean Labs
Bachelor's Degree required with knowledge of GMP requirements.
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Must have strong organizational skills and the ability to work as part of a team.
Must have strong communication skills and experience working cross-functionally and across sites within GPS.
Proficient in common computer software applications, experience with LIMS and LES computer applications a plus.
Practical experience with health authority inspections is preferred.
Minimum of 4 years experience in a related biopharmaceutical GLP or GMP laboratory preferred.
Lean methodology – including those obtained through yellow and green belt trainings is preferred.
Direct daily interaction with all staff and management of QC. Regular interaction with all departments within the facility and with other BMS sites as required to support assigned work.
Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may include periodic night shift or weekend assignments.
May work on assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Exercises judgment within generally defined practices and policies in developing improved business processes. Coordinates with customers and technical experts on decisions and applies appropriate notification to management.
Work is performed under general direction. Independently determines and develops approach to solution. May receive assignments which have a partially defined process with the objective of driving it to completion.
Quality Assurance Floor Support Lead, 3Rd Shift
Provide Quality assistance and oversight during manufacturing of in-process intermediates and drug substance, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.
Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data.
Contributes to driving innovation through continuous improvement of quality processes as well as supporting manufacturing continuous improvement initiatives.
May provide guidance to less experienced staff.
Supports the Quality review and closure of manufacturing investigations.
Other duties as assigned.
This position is a Night Shift (3rd Shift) position that requires working hours of 5:00 pm to 5:00 am EST.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.
QC Technical Support-Bioanlytical Associate Scientist
The Quality Control Associate Scientist will lead or support the method technical transfer and/or validation activities for a cGMP biologics commercial and clinical manufacturing analytical laboratory. This role will act as a Subject Matter Expert (SME) for analytical methods such as ELISA, qPCR, and Biacore, providing technical support for the QC Operations Analytical Chemistry group. The role will require flexibility, high attention to detail, and a quality-driven mindset. This opportunity will allow the QC Associate Scientist to become a member of diverse project teams across a global, matrix organization.
Responsibilities and Requirements include:
Author and review technical documents such as technical transfer protocols and reports.
Troubleshoot QC analytical methods and equipment.
Review and approve QC analytical lab data.
Work independently to execute successful assay executions.
Ability to recognize anomalous trends or results.
Ability to quickly adapt to change and adjust tasks in order to reach shared business goals or timelines.
Knowledge in QC analytical equipment qualifications (IQOQPQ) and decommissioning.
Front room regulatory agency (FDA, EMA) inspection involvement.
Knowledge in cGMP regulations as referenced in The Code of Federal Regulations.
Provide technical support for CAPAs, lab investigations, out of trend alerts, and OOS results for QC analytical methods.
Experience using equipment such as Specrtramax, Biacore, and Quant Studio.
Proficiency in analytical methods such as ELISA, qPCR, and Biacore Binding.
Proficiency in software applications such as Softmax Pro, Trackwise, and LIMS.
Familiar with QC systems such as electronic notebooks and LIMS.
Develop training approach for new methods.
Develop and implement innovative, continuous improvement techniques.
BS / MS or equivalent, preferably in Biological Sciences.
Minimum of 4 years (MS) / 6 years (BS) relevant experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.
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