22 Mar, 2024

Process Engineer I, Manufacturing Engineering

  • Thermo Fisher Scientific
  • Plainville, MA, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Job Description

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

At the Plainville site, 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.

Location/Division Specific Information

Plainville, MA

How will you make an impact?

Responsible for the support of clinical and commercial drug manufacturing in the new Viral Vector Manufacturing facility located in Plainville, MA. Scope includes designing, specifying, and supporting manufacturing equipment such as fill lines, bioreactors, chromatography and TFF systems, autoclaves and analytical equipment in our newly built viral vector facility. Individual will join an experienced team of process and automation engineers working closely with groups such as manufacturing, quality assurance, quality control and validation.

What will you do?             

  • Implement manufacturing equipment involved 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, and fill/finish operations, including support of FAT, SAT, and commissioning/qualification activities.
  • Participate in multi-functional teams for process equipment introduction and modification.
  • Support the development of equipment specifications for manufacturing equipment and prepare equipment lifecycle documentation such as user requirements, instrument assessments, and preventative maintenance plans.
  • Work with equipment suppliers to acquire quotations and handle supplier relationship through equipment procurement, fabrication, delivery, site testing, installation, and operation.
  • Build and maintain relationships with other VVS sites and within the Plainville site to develop and promote engineering standard methodologies and ensure compliance with VVS SOPs, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality, and other engineering teams.
  • Position requires ability to support on-call requirements for client programs. Colleagues will be readily available to respond to production needs outside of core business hours ensuring business continuity. The on-call responsibilities typically rotate weekly through the engineering team.

How will you get here?

Education:

  • BS - Automation, Electrical, Chemical, Mechanical Engineering or related field – required.

Experience

  • Minimum of 0-2 years of experience in the biotech engineering/manufacturing environment
  • Experience with biologic drug manufacturing preferred

Knowledge, Skills, Abilities

  • Exposure to cGMP environment
  • Understanding of general cGMP standards and practices
  • Continuous improvement approach to process and equipment issues
  • Strong interpersonal and communications skills; written and oral
  • Comfortable supporting concurrent issues

We offer excellent opportunities to progress your career along with training and a chance to be a part of a growing successful organization! At Thermo Fisher Scientific, each one of us have a unique story to tell. Join us in our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

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

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