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Validation Project Lead

Company: Masy Systems
Location: Hatfield
Posted on: June 12, 2021

Job Description:

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Description

Masy BioServices is a 37-year-old family owned business which has experienced rapid growth over the past several years. Masy currently has four locations. 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.

Plan, schedule, coordinate, track, and prioritize all facets of a validation project including, but not limited to, prepare validation equipment; direct, support and oversee testing efforts; execute protocols for Installation, Operational and Performance Qualification testing on chambers and rooms including: cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers and warehouses, etc. Also, sterilizer validation using biological indicators and steam quality testing. Process, assemble and review data, generate documentation and reports. Coordinate multiple tasks at one time and coordinate the efforts of the team. Provide training and supervision to validation team members in the office and at project sites. Interface with customers and equipment end users. Timely completion of projects with economic utilization of resources. Meet project objectives in a cost-effective manner.

Requirements

Duties/responsibilities:

  • Pre-requisite to performing calibration procedures: signed off on General Calibration Instructions and M+TE in addition to Temperature, Relative Humidity, CO2, Timer, Rotation, and Pressure Loop Calibration
  • Perform pre- and post-validation verification on test equipment
  • Perform calibrations incidental to the validation including controllers, gauges, recorders, etc.
  • Evaluate customer needs resulting in quotes
  • Create and execute validation protocols, procedures, and final reports
  • Schedule, lead, and perform validation projects
  • Supervise, coach and mentor staff on projects
  • Perform peer review of validation reports
  • Execute troubleshooting strategies in the field
  • Maintain records of pertinent information for the project including project costs reconciliation
  • Evaluate, interpret and give opinions on validation or calibration results - relay opinions and suggestions to clients
  • Independently manage technical writing and documentation aspects of validation reports
  • Write and work with clients to resolve deviations
  • Train, supervise, and manage Validation team members
  • Perform performance reviews on direct reports
  • Troubleshoot, evaluate and document the project and team members performance to improve processes
  • Attend management-approved, external training events
  • Work with Finance department regarding project related billing activities
  • All other duties as assigned

Education/Experience requirements:

  • BA/BS in technical or science related field of study. Candidates with an HSD/GED, technical training, or an Associate's degree combined with mechanical aptitude or relevant industry experience are also encouraged to apply.
  • Five years of direct validation experience

Additional experience/skills:

  • Spreadsheet and word processing applications experience, computer literacy
  • Excellent written and verbal communication skills
  • Proficient with test instruments
  • ISO 9001, ISO 17025, GMP and GLP knowledge
  • Independence and strong background in sterilizer validation
  • Experience and/or demonstrated leadership or supervisory skills

Physical Demands:

  • Drug testing
  • Valid driver's license

Inoculations specific to customer sites

Work environment is office and customer sites

Travel required

Able to lift 50 lbs.

Keywords: Masy Systems, Philadelphia , Validation Project Lead, Other , Hatfield, Pennsylvania

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