Sr Operator, Manufacturing

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, and you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The Frederick, MD location is a critical part of Thermo Fisher’s organization, providing support for up to 5 Business Groups and multiple Divisions, from distribution, to Life Sciences and Corporate support. We are a leading provider of ground breaking products and services. Join our dynamic team in Frederick as a part of our Clinical Sequencing Division, and be part of shaping the future of the world.

Shift Information

Day Shift – Monday through Friday 6am-2:30pm EST. Overtime availability may vary and in certain cases, overtime may be required.

Discover Impactful Work:
The Lead Operator position requires the coordination and writing of cGMP manufacturing batch records, management of problem reports and supporting both internal and external audits. Additional responsibilities include: Updating Standard Operating Procedures (SOP’s) to ensure agreement with batch records and supporting change control for manufacturing value streams. You will be encouraged to possess a scientific background, preferably in life sciences, proven organizational skills, and attention to detail.

A day in the Life:

• Lead and support Problem Reports for each manufacturing value stream to ensure timely closure including but not limited to: NCM's, Planned/Unplanned deviations, Corrective and Preventative Actions.
• Support updating standard operating procedures, work instructions and batch records.
• Continually review existing templates of production records to generate products of consistent quality.
• Collaborate with cross-functional teams to optimize manufacturing document templates as needed.
• Partner with other areas to ensure good quality and cGMP practices with process changes.
• Live the Thermo Fisher Scientific 4Is values every day.
• Occasionally support manufacturing on the floor to view processes.

Keys to Success:

Education

• High school diploma or equivalent required.
• Bachelor’s degree preferred.

Experience

• 2+ years of proven experience, preferably in a cGMP environment
• Experience writing SOP's and/or batch record documents is preferred.
• Proven success working with cross functional teams and provide proactive communication is required.
• Quality and/or financial software (Trackwise, Agile, Documentum, SuccessFactors, etc) skills preferred.

Knowledge, Skills, Abilities

• Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms as well as knowledge of change control processes.
• Ability to work both independently and as part of a team.
• Capability to self-motivate, prioritize work and time.
• Organized, efficient, and results driven.
• Adept in oral and written communication (verbal and written in English), as well as communication skills.
• Computer literate with Microsoft Office tools, including report writing and graphing.

Physical Requirements / Work Environment

• Ability to wear personal protective equipment when required.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

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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