We are looking to fill a Scientist 2 or 3 - Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not support any sponsorship.
Metrology specialist responsible for the oversight of regulated and non-regulated laboratory equipment. This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement
Qualifications - B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline
Scientist 2 - B.S. with 1-2 years of relevant experience or M.S. with no experience
Scientist 3 - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience
Responsibilities
Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation
Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships
Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities
Participate in computer system validation activities associated with new or upgraded equipment or software packages
Support the purchase, installation, and equipment qualification of new laboratory equipment
Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support
Originate and progress Notice of Event (NOE) and Change Management (CM) records
Perform and document investigations and assist in developing/implementing CAPA plans
Represent the laboratory on all aspects of laboratory equipment during audits
Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures
Required Skills and Experience
Experience working within a regulated (GMP) laboratory
Experience maintaining laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems
Familiarity with standalone computer system validation requirements
Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks
Capable of working independently under moderate supervision
Strong verbal and written communication skills
Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators
Desired Skills and Experience
Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them.
Experience with computerized standalone systems GMP validation requirements
Familiarity with authoring relevant instrument standard operating procedures (SOPs)
This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
About Parexel
Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.