When you’re part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact and supported in achieving your career goals.
Location/Division Specific Information: Lexington MA Pharma Services
How will you make an impact?
Partner with manufacturing, automation, and project teams to schedule and maintain electronic record readiness through each phase of the implementation and sustainability plan.
What will you do?
- Develop 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
- Team with Manufacturing, Automation, and project teams to schedule and maintain electronic record readiness through each phase of the implementation and sustainability plan
- Ownership and responsibility for the execution of Process Change Controls and responses to CAPAs (Corrective and Preventative Actions)
How will you get here?
- Bachelors’ in Life Sciences, Engineering, Computer Science or Masters’ degree preferred
- Ideally 5 years’ experience in pharmaceuticals manufacturing
- Minimum 3 years specialist experience preferred
- Background in Automation, PharmaSuite, Rockwell 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
- Conduct troubleshooting on eBRs and MES development environment
- Responsible for the approval and roll out of new/revised SOPs, DCS support, Functional Specifications as part of paper BRs to eBRs conversion and any ongoing process improvements
- Off-hours coverage and support responsibility via a defined hyper-care and support schedule
- Lead MES training as a trainer
- 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 supporting groups required
- Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
- Support and develop consistent manufacturing standards for recipes used within cGMP manufacturing
- Own and maintain tracking systems of MES revisions and priorities
Knowledge, Skills, Abilities
- Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
- Strong planning, organizational 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
- 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
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.