Masy BioServices

Validation Project Leader

US-MA-Pepperell
6 months ago

Overview

Masy BioServices 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 and career growth.

 

In addition, we offer competitive salaries and an excellent benefits package including a matching 401K, health, dental, short term, long term and life insurance.  We also offer holiday pay, sick pay, AAA membership and a clothing allowance.  Masy BioServices is an equal opportunity employer.

 

Job summary:  

 

This position is for day shift, but may require some occasional off shift and/or weekend coverage to accommodate schedules and/or project timelines.

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, sterilizers, depyrogenation ovens, stability chambers and warehouses, etc. Also Steam in Place (SIP) validation using biological indicators. 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.

Responsibilities

Duties/responsibilities:

  • Pre-requisite to performing calibration procedures: signed off on General Calibration Instructions
  • Perform and approve pre- and post qualification on validation sensors
  • Perform calibrations incidental to the validation including controllers, gauges, recorders, etc.
  • Evaluate customer needs resulting in quotes
  • Lead and perform validation projects
  • Document project deviations and suggest solutions
  • Create and execute validation protocols and procedures
  • Maintain records of pertinent information for the project including project costs reconciliation
  • Write, assemble, deliver, approve and present final reports
  • Troubleshoot, evaluate and document the project and team members performance to improve processes
  • Relay opinions or interpretations of calibration results to customer via calibration certificates

Qualifications

Education/Experience requirements:


         AS or BS in engineering or science
         2 years validation experience in the Pharmaceutical or Biotech environment
 

Additional experience/skills:
·         Problem solving skills
·         ISO 9001, ISO 17025 and GMP/GLP experience
·         Kaye equipment expertise: LTR, HTR, CTR, IRTD, Kaye 2000
·         Spreadsheet and word processing applications, computer literacy
·         Relative humidity, CO2 and pressure sensors
·         Supervisory experience, team building skills
·         Proficient with wireless technology
·         Excellent written and verbal communication skills
·         Sterilization techniques
·         Excellent reporting, organizational and interpersonal skills
 

Physical Demands:
·         Drug testing
·         Valid driver’s license
·         Inoculations specific to customer sites
·         Work environment is office and customer sites
·         Extended travel required
·         Able to lift 50 lbs.

 

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