We are looking to fill a Scientist 2 or 3 - Analytical Chemist 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 offer sponsorship.
The Analytical Chemist Metrology Specialist is 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 0-1 years of relevant experience
• Scientist 3 - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience

REQUIRED SKILLS AND EXPERIENCE

• Experience working within a regulated (GMP) laboratory

EXPERIENCE MAINTAINING OR OPERATING 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)

• 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