Instrumentation Engineer

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 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 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.

• 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