Scientist II or III - Metrology Specialist - FSP

Parexel•United States-New Jersey-Remote, NJ

10d•Onsite

About The Position

Parexel FSP is seeking a full-time Scientist II or III - Metrology Specialist to work onsite at one of their clients in Rahway, NJ. This role is responsible for the lifecycle management of regulated and non-regulated laboratory equipment, including acquisition, installation, maintenance, computer system validation, and retirement. Parexel FSP provides qualified technical professionals to support pharmaceutical and biopharmaceutical companies in the development and delivery of new therapies.

Requirements

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
Experience working within a regulated (GMP) laboratory
Experience maintaining, operating, and troubleshooting laboratory equipment including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet-Visible spectroscopy (UV-Vis), dissolution systems, and other specialized computerized systems.
Familiarity with standalone computer system GMP 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
Familiarity with authoring relevant instrument standard operating procedures (SOPs)

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