Specialist, Analytical Instrument Validation

MSD • Rahway, NJ

1d • Hybrid

About The Position

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey research facilities. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP environment for multiple sites (Pennsylvania, New Jersey, and Schachen, CH).

Requirements

• Bachelor’s degree, or higher, in analytical chemistry or related field with 3+ years post-degree relevant industry experience.
• 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 computerized equipment or instrument validation
• Experience working within a GMP environment
• Understanding of GMP policies and procedures

Nice To Haves

• Demonstrated commitment to diversity and inclusion
• Experience with IT, computerized systems, software and applications, including Secure Desktop
• Experience with developing tools (e.g., Power Apps) or utilizing AI.
• 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 computer system validation
• Experience in Instrument commissioning, qualification, and validation (CQV)

Responsibilities

• Partner with scientific teams across DSCS to drive compliance and operational excellence
• Validate novel and time-sensitive instrumentation in GMP environments to 21CFR11 compliance
• Support standardization activities for System Development Life Cycle globally
• Support internal quality and external regulatory audits and maintain laboratory state of permanent inspection readiness within the scope of SDLC
• Contribute to Standard Operating Procedures (SOP) drafting
• Originate and own Investigations and Change Management records
• Contribute to digital innovation activities supporting operational excellence for improved consistency, compliance, and efficiency

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level