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.
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.
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
Strong functional knowledge of:
GxP computer systems (experience in Inventory Management Systems and sterilization technology a plus)
CSV regulatory requirements (US and global)
Risk assessment/analysis methods
Change control methods
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
Inoculations specific to customer sites
Valid driver's license
Work environment is office and customer sites
Able to lift 50 lbs.