Process Engineer III

Job Description

At the Plainville, MA site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies

How will you make an impact?

The Process Engineering III will be responsible for supporting the manufacturing equipment for upstream, downstream and fill/finish operations. This role includes manufacturing operations support role within the Facilities and Engineering team where we support manufacturing, laboratory, and warehouse operations.

What will you do?

The Process Engineer III is responsible for providing

• Support manufacturing equipment engaged in tech transfers of new products into manufacturing and provide continued support throughout manufacturing campaigns.
• Support all aspects of the process equipment for upstream/ downstream or fill/finish equipment, including support of FAT, SAT and commissioning / qualification activities.
• Participate in deviation investigations and supports change control assessments and reviewing/approving change control implementation plans related to utilities, automation, computer systems, validation, methods, and laboratory instruments.
• Leads and participates in multi-functional department teams for process equipment introduction and modification to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
• Support internal and external inspections.
• Drives continuous quality system improvements.
• Develops, monitors, and reports performance metrics.
• Lead responses to process & equipment related issues during production
• Responsible for client facing as a technical lead in delivery of projects and tech transfers.
• Develop equipment specifications for manufacturing and analytical equipment and finds opportunities to improve technical reliability, and other aspects of operational performance
• Collaborates with other VVS sites to develop and promote engineering standard methodologies and ensures compliance with VVS SOP’s, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams

How will you get here?

Education

Bachelor’s degree in engineering, science, or related field, with evidence of operational, leadership, or professional experience.

Experience

• Minimum of 5+ years’ experience in process development, operation or engineering in the biologics manufacturing industry
• Experience with project management
• Experience with biologics drug substance and/or drug product manufacturing
• Experience with single-use technologies
• Experience with drug product filling and isolator technologies

Knowledge, Skills, Abilities

• Working understanding of general cGMP standards and practices
• Understanding of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems
• Understanding of applicable regulatory requirements. Audit experience is helpful.
• User documentation review and revision experience
• Ability to set goals and direction for others both on-site and remote based team members
• Comfortable supporting concurrent issues and working in an exciting, bold, and fast-paced environment
• High ethical standards to support a professional business code of conduct.

At Thermo Fisher Scientific, each one of our colleagues have an outstanding story to tell. Join us in our mission—enabling our customers to make the world healthier, cleaner, and safer.

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

Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations. 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. 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.

Salary : $40 - $0