Thermo Fisher Scientific Engineer I [MES] in Lexington, Massachusetts
Job Title: Engineer I [MES]
Work Location: Lexington, MA
Division: Pharma Services Group (PSG)
How will you make an impact?
The specialist in this role will be part of a cohesive team responsible for supporting the development and maintenance of new Electronic Batch Records (eBRs) and associated automated modules. The Manufacturing Execution System (MES) Specialist uses expert knowledge of cGMP regulations and project management to support manufacturing system design and maintenance. The individual will assist in configuration/customization of the system, participate maintaining necessary procedures, and provide system training to users.
What will you do?
Support development of new electronic batch records (eBRs) and revising existing eBRs using a library of work instructions and operations.
Create new electronic workflows as assigned. Participates/lead end-user testing requirements and incorporate identified changes from recipe review processes.
Collaborate with Manufacturing, Automation, and project teams to schedule and maintain electronic record readiness through each phase of the implementation and sustainability plan.
Assist in the execution of Process Change Controls and responses to CAPAs (Corrective and Preventative Actions).
Conduct troubleshooting on eBRs and MES development environment.
Support the approval and roll out of new/revised SOPs and Functional Specifications as part of paper BRs to eBRs conversion and any ongoing process improvements.
Off-hours coverage and support responsibility via a defined hypercare and support schedule.
Create, assign, perform, and maintain training for manufacturing staff, for MES systems.
Edit cGMP documents and process through workflow for the creation of quality approved documentation. Cross-functional collaboration with document control and other supporting groups is required.
Support training for manufacturing staff, for MES systems.
Support and develop consistent manufacturing standards for recipes used within cGMP manufacturing.
Own and maintain tracking systems of MES revisions and priorities
How will you get there?
- Bachelor’s in Engineering, Computer Science, Life Sciences, or Masters preferred.
Minimum of 1 to 3 years experience in pharmaceuticals manufacturing. Minimum 1 year specialist experience preferred.
Experience with Manufacturing Execution Systems (MES) and automated systems required.
Background in implementing or software engineering for MES systems (ex.- weigh and dispense, EBR, integration), preferably in a regulated or pharmaceutical production environment preferred.
Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
Strong project management, organization and multitasking skills.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Ability to make decisions and work with minimal to moderate supervision.
Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups
Solid understanding of applicable regulatory requirements.
Knowledge, Skills, Abilities
Gown aseptically and/or sterile gown as needed.
Write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.
The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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