Validation Project Lead
Company: Masy Systems
Posted on: June 12, 2021
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.
- 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
- Perform pre- and post-validation verification on test
- 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
- 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
- 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
- All other duties as assigned
- 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
- Spreadsheet and word processing applications experience,
- Excellent written and verbal communication skills
- Proficient with test instruments
- ISO 9001, ISO 17025, GMP and GLP knowledge
- Independence and strong background in sterilizer
- Experience and/or demonstrated leadership or supervisory
- Drug testing
- Valid driver's license
Inoculations specific to customer sites
Work environment is office and customer sites
Able to lift 50 lbs.
Keywords: Masy Systems, Philadelphia , Validation Project Lead, Other , Hatfield, Pennsylvania
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