Validation Engineer II

Masy Systems Pepperell , MA 01463

Posted 2 months ago

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Description

Masy BioServices is a 35-year-old family owned business which has experienced rapid growth over the past several years. Masy currently has four locations and over 150 employees. We provide services to pharmaceutical, biotech and medical device industries.

Our reputation has been built around the quality and experience of our staff. We have carefully built a dynamic team whose members possess diverse professional skills. We offer a casual, friendly atmosphere, promoting individual development, career growth and industry association opportunities.

We offer competitive salaries and an excellent benefits package including a matching 401K, health, dental, short term and long term disability and life insurance. We also offer holiday pay, PTO, education reimbursement, AAA membership and a clothing allowance.

Masy BioServices is an equal opportunity employer.

Job summary:

Responsibilities for this position involve validation equipment preparation, protocol execution and final report generation. This position will support a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, sterilizers, depyrogenation ovens, stability chambers, warehouses, CSV etc. Interface with customers and equipment end users.

This full-time position works with minimal supervision and will independently work onsite with small projects. The position is for day shift but may require occasional off-shift and/or weekend coverage.

Duties/responsibilities:

  • Pre-requisite to performing calibration procedures: signed off on General Calibration Instructions and M+TE in addition to Temperature, Relative Humidity, and CO2 Loop Calibration

  • Perform pre- and post-validation verification on test equipment

  • Perform calibrations incidental to validation including controllers, gauges, recorders, etc.

  • Create and execute validation protocols, procedures, and final reports; perform validation projects

  • Perform peer review of validation reports

  • Learn and execute troubleshooting strategies in the field

  • Independently manage technical writing and documentation aspects of validation reports

  • Write and work with clients to resolve deviations

  • Maintain records of pertinent information for the project including project costs reconciliation

  • Relay opinions or interpretations of results to customer

  • All other duties as assigned

Requirements

Education/Experience requirements:

  • Bachelor's degree in Electrical Engineering, Computer Science or related technical discipline is preferred
  • 5 years of CSV & Automation experience in BioPharma industry is preferred, to include generation of qualification protocols, related documentation and test execution of software-based systems

Strong functional knowledge of:

  • GxP computer systems (experience in Inventory Management Systems and sterilization technology a plus)

  • CSV regulatory requirements (US and global)

  • GAMP5

  • Risk assessment/analysis methods

  • Change control methods

Additional experience/skills:

  • Spreadsheet and word processing applications experience, computer literacy

  • Strong written and verbal communication skills

  • Proficient with test instruments

  • ISO 9001, ISO 17025, GMP and GLP knowledge

  • Project management experience is a strong plus

Physical Demands:

  • Drug testing

  • Inoculations specific to customer sites

  • Travel required

  • Valid driver's license

  • Work environment is office and customer sites

  • Able to lift 50 lbs.

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Validation Engineer II

Masy Systems