Engineer Iii, Drug Substance, Manufacturing Engineering

Thermo Fisher Scientific Cambridge , MA 02138

Posted 2 months ago

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

  • Location/Division Specific Information

Cambridge, 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 at the Cambridge, MA campus. Scope includes designing, specifying, and supporting manufacturing equipment such as isolators, fillers, autoclaves and analytical equipment in our newly built viral vector manufacturing facility. Individual will be part of 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? *

  • Lead Facility Fit Assessments for the Engineering Team for Potential New Products

  • Drive implementation and standardization of equipment into the manufacturing areas

  • Harmonize the equipment platforms for to ensure redundancy across the different clients within the Thermo Fisher Cambridge Site
    This scope will also include aligning/coordinating capabilities across sites within the company while ensuring that the capabilities of the Cambridge site meets all regulatory requirements necessary for commercial manufacturing. This person will be responsible for working with tech transfer teams, manufacturing and clients to support client campaigns.

  • How will you get here?
    Education*

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

  • Experience*

  • Minimum of 5 years of experience in the biotech engineering/manufacturing environment.

  • Experience with cGMP equipment such as bioreactors, chrom systems, and single use mixers

  • Experience with downstream or biologic drug manufacturing

  • Understanding of general cGMP standards and practices

  • Knowledge, Skills, Abilities*

  • Exposure to cGMP environment.

  • Knowledge of testing and associated equipment protocols and requirements and applicable equipment

  • Candidate must also have the capability to define user requirements in support of designing or procuring manufacturing equipment

  • Strong interpersonal and communications skills; written and oral.

  • Basic understanding of applicable regulatory requirements.

  • Technical documentation review and revision experience.

  • Working with both hands-on and remote based staff

  • Ability to work independently

  • Comfortable supporting concurrent issues.
    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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Engineer Iii Drug Substance Manufacturing Engineering

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VIEW JOBS 9/27/2021 12:00:00 AM 2021-12-26T00:00 Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Location/Division Specific Information Cambridge, 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 at the Cambridge, MA campus. Scope includes designing, specifying, and supporting manufacturing equipment such as isolators, fillers, autoclaves and analytical equipment in our newly built viral vector manufacturing facility. Individual will be part of 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? * Lead Facility Fit Assessments for the Engineering Team for Potential New Products * Drive implementation and standardization of equipment into the manufacturing areas * Harmonize the equipment platforms for to ensure redundancy across the different clients within the Thermo Fisher Cambridge Site This scope will also include aligning/coordinating capabilities across sites within the company while ensuring that the capabilities of the Cambridge site meets all regulatory requirements necessary for commercial manufacturing. This person will be responsible for working with tech transfer teams, manufacturing and clients to support client campaigns. How will you get here? Education * BS - Automation, Electrical, Chemical, Mechanical Engineering or related field - required. Experience * Minimum of 5 years of experience in the biotech engineering/manufacturing environment. * Experience with cGMP equipment such as bioreactors, chrom systems, and single use mixers * Experience with downstream or biologic drug manufacturing * Understanding of general cGMP standards and practices Knowledge, Skills, Abilities * Exposure to cGMP environment. * Knowledge of testing and associated equipment protocols and requirements and applicable equipment * Candidate must also have the capability to define user requirements in support of designing or procuring manufacturing equipment * Strong interpersonal and communications skills; written and oral. * Basic understanding of applicable regulatory requirements. * Technical documentation review and revision experience. * Working with both hands-on and remote based staff * Ability to work independently * Comfortable supporting concurrent issues. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. Thermo Fisher Scientific Inc. Cambridge MA

Engineer Iii, Drug Substance, Manufacturing Engineering

Thermo Fisher Scientific