Director Computer System Validation Csv Jobs in Decatur, MI

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are looking to fill a Scientist II or III - Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.

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, 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

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.

Come join us!

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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.