Job details
Job type full-time
Full job description
Thermo fisher scientific incIs the world leader in serving science, with annual revenue exceeding $25 billionOur mission is to enable our customers to make the world healthier, cleaner and saferWhether 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 therapiesPlaced 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 campusScope includes designing, specifying, and supporting manufacturing equipment such as isolators, fillers, autoclaves and analytical equipment in our newly built viral vector manufacturing facilityIndividual 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 manufacturingThis 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 incIs the world leader in serving science, with annual revenue exceeding $25 billionOur mission is to enable our customers to make the world healthier, cleaner and saferWhether 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 themOur 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 patheonFor more information, please visit www.thermofisher.com.