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Thermo Fisher Scientific Validation Specialist in Cambridge, Massachusetts

Job Title : Validation Specialist, VVS Quality Control Analytical Instrument Validation

Requisition ID : 130853BR

Location : Cambridge, MA

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

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.

How will you make an impact?

This Validation Specialist is responsible for supporting analytical instrument and equipment qualification, computer system validation, and calibration and maintenance projects for the Quality Control labs at the Cambridge site of VVS.

What will you do?

  • Validation documentation development and execution including GxP and 21 CFR Part 11 Assessments, Change Control, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Supplemental IQ/OQ/PQ Protocols, Traceability Matrices, Summary/Final Reports, and Standard Operating Procedures according to company procedural requirements.

  • Develop and oversee a calibration and preventive maintenance program for all laboratory assets in QC.

  • Collaborate with Facilities, Engineering, Metrology teams on in-house calibration & maintenance. Establish and maintain third-party or vendor contracts for external services.

  • Manage schedule for vendor preventive or corrective maintenance and instrument system installations. Host vendor onsite visits. Review/approve vendor service documentation and file in maintenance database or per applicable procedures.

  • Perform periodic review of instrument system audit trails; investigate and document any exceptions.

  • Serve as administrator for instrument-related software applications; author or review related SOPs.

  • May be required to assist with computer system or Excel spreadsheet validation.

  • Oversee data integrity as applicable to analytical instrumentation in the QC laboratory.

How will you get here?

Education

  • BS in a life science, engineering or equivalent work experience

Experience

  • 3+ years of related industry experience, preferably in a GxP regulated setting (Laboratory, Quality, Validation, IT).

Knowledge, Skills, Abilities

  • Familiarity with a variety of Laboratory Instrumentation/Equipment - Chemistry/Microbiology/Molecular Biology - and instrument-related software applications.

  • Experience with calibration and maintenance management software applications.

  • Experience with data integrity

  • Experience with electronic document management applications.

  • Exposure to lab operations, client and regulatory inspections, basic lab safety and scientific processes associated with supporting QC laboratory functional areas.

  • Understanding of GxPs, GAMP, CFRs / Annex 11, Data Integrity as they relate to laboratory systems. Understanding of the Validation Lifecycle (GAMP 5).

  • Understanding of applying SOPs, work instructions and regulatory requirements to managing instruments and equipment.

  • Ability to work independently and as a group on multiple projects at once.

  • Ability to act as a liaison between IS, Engineering, Facilities, Metrology and Laboratory Departmental Management.

  • Ability to collaborate with Quality Assurance for review and approval of documentation.

  • Detail oriented with strong verbal and written communication skills (e.g., technical and legible writing skills related to generating qualification documents, SOPs and work instructions, etc.).

  • Ability to function in a dynamic environment and balance multiple priorities simultaneously.

  • Ability to make decisions and work with minimal to moderate supervision.

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 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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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