Senior Specialist, Metrology and Validation

Job Description

Title: Senior Specialist, Metrology and Validation, Pharmaceutical Analysis & Digital Technologies

Job Description 

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is seeking applicants for an Metrology and Validation Specialist position available at the West Point, Pennsylvania research facility. 

The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation within a GMP environment.

The key responsibilities of this role will include:

• Partner with scientific teams across DSCS to drive compliance and operational excellence

• Onboard, qualify, and maintain laboratory equipment and instrumentation in both GMP and non-GMP environment

• Lead laboratory computer system validation activities associated with new or upgraded instrumentation or software packages in compliance with 21CFR11 compliance requirements.

• Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories

• Support internal and external quality audits and maintain laboratory state of permanent inspection readiness

• Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories

• Originate and own Investigations and Change Management records

• Mentor and coach junior metrology and validation specialists; overseeing day to day assignments.

• Collaborate with cross-functional teams to deliver department level priorities   and initiatives.

The successful candidate must function both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.  Strong communications skills and eagerness to adapt and learn are essential attributes.  As a member of our team, you will be joining scientific and technical problem solvers who are dedicated to creating the life-changing medicines of tomorrow.  

Education Minimum Requirements (standard for each level) 

Bachelor’s degree, or higher, in analytical chemistry, biotechnology,  or related field with 5+ years post-degree relevant industry experience. Metrology and/or validation experience preferred.

Required Experience and Skills 

• A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives 

• Proven track record of strong technical and innovative problem solving

• Desire and ability to learn new concepts outside of core expertise and training  

• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills 

• Related industry experience with metrology and equipment maintenance and calibration.

• Experience working within a GMP environment. 

• Understanding of GMP policies and procedures.

Preferred Experience and Skills 

While not required, experience in one or more of the following areas is beneficial. 

• Demonstrated commitment to diversity and inclusion 

• Experience leading a team for a common goal 

• Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management.

• Experience supporting internal and external quality audits.

• Experience in Instrument commissioning, qualification, and validation (CQV)

• Experience in instrument computer system validation

• Experience with IT, computerized systems, software and applications, including Secure Desktop

• Experience with developing tools (e.g., Power Apps) or utilizing AI.

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