Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

We at Microbial Material Services (MMS), a new Business Unit within Thermo Fisher Scientific’s Pharma Services Group, deliver the expertise and resources vital to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and ground breaking Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

How will you make an impact?

We ensure process equipment readiness and facility fit in support of clinical and commercial GMP plasmids. Demands are met in accordance with established quality, efficiency and regulatory standards. The Engineer will lead planning, execution, and internal / external customer interactions for continuously improving the manufacturing operations process at the plant/site. S(he) will support manufacturing team on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. S(he) will work closely with colleagues in MSAT, PD, Quality, EHS, Commercial, and Manufacturing to ensure compliance, successful technology transfers and process improvements.

What will you do?

• Work with Process Development and MSAT teams to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include fermentation, cell lysis, chromatography, ultrafiltration, and depth filtration.
• Represent Process Engineering in Internal and Customer meetings and make sound evidence-based contributions.
• Lead projects with supervisor oversight
• Actively drive engineering initiatives to improve practices and procedures
• Provide technical guidance for GMP deviations. Help devise and Implement Corrective Actions.
• Implement changes to equipment and processes
• Document procedures via Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
• Review and contribute to documents created by other departments, such as Tech Transfer Protocols, Equipment Preventive Maintenance Procedures and SOPs
• Provide on-floor technical support for manufacturing processing, as needed.

How will you get here?

Education:

• Minimum required education: Bachelor’s degree in Engineering

Experience:

• 2 + years within a GMP Environment
• 3 + years of experience in engineering
• Experience with process equipment for the following systems: fermenters, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.

Knowledge, Skills, and Abilities:

• Proficient with computers (MS Office).
• Mechanical & technical ability/proficiency
• Analytical problem-solving skills
• Good business decisions using both cost and risk analysis
• Good communication and presentation skills (verbal and written in English)
• Unquestionable integrity
• Balance multiple tasks, issues, projects
• Work independently and as a part of a team
• Proven understanding of controlled documentation and data systems.
• Understanding and/or knowledge of change control and performing process impact assessments
• In depth knowledge of cGMP regulations.
• Understands microbial production processes and the production environment
• Extensive knowledge of plasmid / microbial manufacturing processes and equipment preferred.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global 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! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The salary range estimated for this position based in California is $90,000.00–$100,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards