Specialist, Global Analytical Instrument Validation (On-site)

Merck • Upper Gwynedd Township, PA

2d • $96,200 - $151,400 • Onsite

About The Position

The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities and Operations (ACO) department in the Research & Development Division is hiring an Analytical Instrument Validation Specialist at the West Point research facility. This role is part of the integrated Validation and Compliance team and supports quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The specialist oversees and/or supports validation of novel computerized analytical instrumentation in GMP laboratories across sites in Pennsylvania, New Jersey, and Schachen, Switzerland.

The successful candidate works independently and collaboratively in a fast-paced, integrated, multidisciplinary team. The role calls for strong communication skills and a willingness to adapt and learn, including learning concepts beyond the candidate’s core expertise and training.

Requirements

• Bachelor’s degree or higher in analytical science, information technology, or a related field.
• At least 3 years of relevant post-degree industry experience.
• Ability to work independently and cross-functionally as a strong team player to deliver complex objectives.
• Proven technical and innovative problem-solving ability.
• Desire and ability to learn new concepts outside core expertise and training, including applications of or for Artificial Intelligence (AI).
• Excellent verbal and written communication, creativity, and strong interpersonal skills.
• Related industry experience with computerized equipment or instrument validation.
• Experience working within a GMP environment and 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 developing tools such as Power Apps or using AI.
• Experience leading a team toward a common goal.
• Pharmaceutical-industry auditing and compliance experience, including change management and deviation management.
• Experience supporting internal and external quality audits.
• Experience in instrument computer system validation.
• Metrology.

Responsibilities

• Partner with scientific teams across DSCS to drive compliance and operational excellence.
• Validate novel and time-sensitive instrumentation in GMP environments in compliance with 21 CFR Part 11.
• Support global standardization activities for the System Development Life Cycle (SDLC).
• Support internal quality and external regulatory audits and maintain laboratory inspection readiness within the scope of SDLC.
• Contribute to drafting Standard Operating Procedures (SOPs).
• Originate and own investigations and change management records.
• Contribute to digital innovation activities that improve operational consistency, compliance, and efficiency.

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

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