11 Apr, 2022

Process Engineer III

  • Thermo Fisher Scientific
  • Plainville, MA, USA
Process Engineer Chemicals

Job Description

At the Plainville 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. The initial focus of the position will be supporting the execution of a large capital facility project from construction and operational readiness activities for a state-of-the-art new commercial manufacturing facility. This role will transition into primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory, and warehouse operations.

What will you do?

In operations, 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
  • 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 for the subject matter
  • Helps drive 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 specification of manufacturing and analytical equipment and finds opportunities to improve robustness, reliability, and other aspects of operational performance
  • Build and maintain relationships 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 is required 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 people and project management
  • Experience with biologics drug substance and/or drug product manufacturing is preferred
  • Experience with single-use technologies is preferred
  • Experience with drug product filling and isolator technologies is preferred
  • Experience with VHP sanitization is strongly desired

Knowledge, Skills, Abilities

  • Working understanding of general cGMP standards and practices
  • Solid understanding of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems
  • Strong understanding of applicable regulatory requirements. Audit experience is preferred.
  • Strong technical documentation review and revision experience
  • Strong interpersonal and communications skills; written and oral
  • 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, ambitious, and fast-paced environment
  • High ethical standards to support a professional business code of conduct.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us in our singular 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.

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