Quality Validation Specialist (Pharma, Temp-to-Perm)(s513)

  • Contract Duration: 6+ months, Onsite
  • Manufacturing
  • Waltham, MA

Website Lenox Executive Search

Job description

6+ Month Contract ONSITE role with strong potential to convert to Permanent. Must have 2+ years for QAV (Quality Validation) Experience. Rate commensurate with experience.

Lenox Executive Search is seeking an experienced Quality Validation Specialist to fill a Temp-to-Perm role with a global pharmaceutical company in Waltham, MA. Must have previous experience in QAV role, including pre-execution review and post-execution review.

REQUIREMENTS for the Quality Validation Specialist:

  • Bachelor’s (or post-graduate degree) in a relevant field to the biotech or pharmaceutical industry.
  • Must have 2+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries.
  • Previous QAV (QUALITY VALIDATION) role, pre-execution review and post-execution review.
  • QUALIFICATION activity experience – Experience qualifying equipment – categories, Laboratory equipment, computer systems validation equipment, CMMS
  • Strong Experience with Documentation &SOP’s
  • Previous experience reviewing and approving protocols
  • Experience working with Vendors preferred
  • Must have 2+ years of experience in working with facility start ups, factory/ site acceptance testing, commissioning/Qualification activities and all associated supporting documentation generated during the course of these activities.
  • Experience with continuous improvement of Validation operations in response to business needs and customer audits/regulatory inspections.
  • Experience in execution of field activities associated with validation protocols, project plans, data analysis, a compilation of data into final reports and project summary/close out.
  • Experience in asset management and in NIST traceability to standards
  • Demonstrated experience in working in compliance with US, EU and ICH GMP requirements.
  • Preferable experience in early-phase clinical efforts, which are not under the stringent requirements of a commercial facility.
  • Preferable experience in supporting a Phase I/II company up through commercialization.
  • Excellent oral and written communication skills.
  • Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts.

RESPONSIBILITIES of the Quality Validation Specialist:

  • Maintenance phases of the Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment.
  • Author the necessary Validation Protocols and Project Plans, and support all field activities performed in support of their execution.
  • Help drive on time deliverables in a compliant manner, while serving as the Validation
  • Subject Matter Expert and interacting with customers on their needs.
  • Serve as liaison and cross-functional lead with Engineering, Manufacturing and Quality
  • Assurance to provide an overall compliant program with industry standard
  • Help review proposed changes to validated systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change
  • Help enforce compliance to senior leadership strategy and direction, as it pertains to the areas of cleaning validation, equipment validation, computer systems validation and routine maintenance of validated systems.
  • Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs.
  • Support the site-wide calibration and maintenance program for all Sanofi mRNA CoE owned GxP equipment and systems.
  • Support the planning, scheduling and completion of all Metrology work performed to ensure timely maintenance and calibration activities on Sanofi’s mRNA CoE owned equipment and systems.
  • Help investigate and support management in all investigation

Job Types: Contract, Temp-to-hire

Salary: $45.00 – $60.00 per hour

Experience level:

  • 2 years


  • Monday to Friday

Work setting:

  • In-person

Ability to commute/relocate:

  • Waltham, MA: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

  • Are you vaccinated?



  • Bachelor’s (Required)


  • Quality validation in the Pharma/Biotech industry: 2 years (Required)
  • Qualification: 2 years (Preferred)
  • Reviewing and approving protocols: 2 years (Preferred)
  • QAV -pre-execution review and post-execution review: 2 years (Preferred)
  • Equipment qualifying: 1 year (Preferred)
  • working with Vendors: 1 year (Preferred)
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