Process Engineer II, MSAT

Saint Louis, MI - USA

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)

Job Description

Process Engineer II MSAT

Division/Site Specific Information

Our St. Louis MO biologics development and manufacturing facility is a recognized Center of Excellence for bioprocessing and single-use technology (S.U.T.). The site features the Bioprocessing Collaboration Center (BCC) and the Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactors (S.U.B.s).

Here our experts work with high-capital equipment and advanced resources to create customized and optimized process development and scale-up solutions for bispecifics Fc-fusion proteins IgG1 IgG4 and other complex protein-based biologics. This environment supports innovation technical ownership and close collaboration across manufacturing development and quality teams.

Discover Impactful Work

At Thermo Fisher Scientific our mission is to enable our customers to make the world healthier cleaner and safer. As part of our global team of 100000 colleagues youll work alongside experts driven by our values of Integrity Intensity Innovation and Involvement.

As a Process Engineer II MSAT you will play a critical role in supporting customer programs and internal technology initiatives by providing technical expertise across manufacturing validation and process improvement activities in a GMP biologics environment.

How Will You Make an Impact

You will serve as a technical contributor and emerging technical owner for manufacturing processes supporting the Process Engineering / MSAT team in a fast-paced 24/7 biologics manufacturing facility. Through cross-functional collaboration with Operations Quality Assurance Process Development and occasionally customers you will help ensure robust compliant and scalable manufacturing solutions.

A Day in the Life

Draft and maintain Standard Operating Procedures (SOPs) and Job Aids
Collaborate with Process Development to assess standardized methodologies and learn new unit operations at manufacturing scale (cell culture harvest purification)
Contribute to internal and customer meetings supported by data and sound scientific rationale
Manage internal projects and support client projects including timeline management
Identify error-proofing opportunities and drive engineering improvements to practices and procedures
Provide scientific and technical support for GMP deviations assessing impact to product quality and process validation
Lead changes to equipment and process design
Draft review and approve:
- Manufacturing Batch Records
- Performance Qualifications (PQs)
- Process Validation protocols
- Process Flow Diagrams
- Automation methods
- Bills of Materials (BOMs)
Draft process control documents campaign summary reports and process validation reports
Review analyze and trend process data with minimal supervision
Provide technical feedback on documents from other departments (e.g. Tech Transfer Protocols SOPs)
Troubleshoot technical issues on the manufacturing floor including on-call support and occasional weekend coverage
Support site-wide MSAT initiatives focused on patient safety compliance and customer delivery
Provide development and training support for Process Engineers and Scientists

Keys to Success

Education

Bachelors degree required in a scientific discipline; engineering preferred
Masters degree may be considered in lieu of some experience

Experience

2 years of experience in a GMP-regulated biologics or pharmaceutical manufacturing environment
Working knowledge of current Good Manufacturing Practices (cGMPs) and US/EU regulations
Experience supporting manufacturing validation or MSAT activities

Knowledge Skills and Abilities

Knowledge

Foundation in general scientific principles and pharmaceutical manufacturing practices
Basic understanding of statistical methods for pharmaceutical process analysis (preferred)

Skills

Strong written and verbal communication skills
Proficiency in Microsoft Word and Excel
Ability to review analyze and trend manufacturing and process data

Abilities

Ability to self-motivate prioritize and manage time effectively
Ability to work independently and collaboratively in cross-functional teams
Ability to gown and work in manufacturing environments and stand for prolonged periods

Physical Requirements / Work Environment

Work in a GMP manufacturing environment
Ability to gown into classified areas
Ability to support a 24/7 manufacturing operation including on-call and weekend coverage as needed

Excellent Benefits

Thermo Fisher Scientific offers a competitive compensation and benefits package including:

Medical Dental and Vision benefits effective Day 1
Paid Time Off and designated paid holidays
Retirement Savings Plan
Tuition Reimbursement

Relocation assistance is not provided

Must be legally authorized to work in the United States now and in the future without sponsorship

Must be able to pass a comprehensive background check including drug screening

Required Experience:

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (...