Vacancy expired!
Job Description
- Responsible for the timely installation, maintenance, repair, calibration, and IQ/OQ for instruments, balances and other equipment used by the Analytical Development (AD) and Quality Control (QC) groups
- Revises and reviews metrology-related protocols and IQ/OQ to ascertain proper functioning of the instrumentation. Ensures that appropriate documentation for the instrument calibration program is in place for compliance with regulatory expectations
- Schedules, executes and supports instrument calibrations and preventative maintenance in such a way so as not to disrupt the analysts using the instruments. Responsible in the assignment of instrument custodians, assuring instrument maintenance and usage logbooks have been maintained
- Negotiates and manages contracts with external vendors and contracted services as required. Oversees the work of contracted personnel to install/modify equipment and systems in accordance with the specific needs of the AD and QC groups while meeting all cGMP and USP requirements
- Keep abreast of instrument validation requirements to ensure compliance with respect to USP and cGMP requirements
- Provides assistance in internal and customer audits by providing relevant, up to date documentation related to calibration, qualification and maintenance of appropriate analytical instrumentation used by the analytical groups
- Leads the process to evaluate, purchase and install new instrumentation
- Interacts with internal and external vendors to ensure the proper instrumentation is identified to support the needs of the business
- Evaluates and recommends appropriate application of new software packages as well as upgrades of software/firmware/hardware
- Involved with and supports investigations that are instrument related
- Conducts all work in compliance with USP and cGMP standards and all other appropriate Federal, state and local regulations
Qualifications
- Bachelor’s Degree in chemistry,mechanical engineering, or a related science with a minimum of 5 years’ related experience
- Familiarity with USP and cGMP regulations. Experience in a cGMP environment is preferred
- Experience with HPLC instrumentconfiguration and/or repair
- Experience or familiarity with Labware LIMS and the Instrument Manager module
- Experience or familiarity with Master Control and Trackwise
- Recent relevant experience in bulk pharmaceutical/API manufacturing or specialty chemicals
- Ability to exercise independent judgment in the application of scientific principles pertaining to analyses as related to this business and operation
- Proficiency with computers and other software packages relevant to installation, modification, calibration and qualification of instrumentation systems and equipment
- Strong written and verbal communication skills
- Possess strong organizational skills
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Devens, MAare encouraged to apply.
What we offer:- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins Lancaster Laboratories Professional Scientific Services®(PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.
Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Vacancy expired!