Specialist, Global Analytical Instrument Validation (On-site)
About The Position
The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities and Operations (ACO) department within the Research & Development Division is seeking a Validation Specialist at the West Point research facility. As part of the integrated Validation and Compliance team, the role supports quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. It oversees and/or supports validation of novel computerized analytical instrumentation in GMP laboratory environments across multiple sites in Pennsylvania, New Jersey, and Schachen, Switzerland. The successful candidate will work independently and collaboratively in a fast-paced, multidisciplinary team. Strong communication skills and a willingness to adapt and learn are important. The role involves supporting global system development life cycle standardization, GMP compliance, audit readiness, and digital innovation.
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 both independently and cross-functionally as a strong team player to deliver complex objectives.
- Proven technical and innovative problem-solving ability.
- Willingness and ability to learn concepts outside core expertise and training, including applications of or for Artificial Intelligence (AI).
- Excellent verbal and written communication, creativity, and interpersonal skills.
- Related industry experience with computerized equipment or instrument validation.
- Experience working in 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 utilizing AI.
- Experience leading a team toward a common goal.
- Experience in pharmaceutical-industry auditing and compliance, including change management and deviation management.
- Experience supporting internal and external quality audits.
- Experience in instrument computer system validation.
- Metrology experience.
Responsibilities
- Partner with scientific teams across DSCS to drive compliance and operational excellence.
- Validate novel and time-sensitive instrumentation in GMP environments to 21 CFR Part 11 compliance.
- Support global standardization activities for the System Development Life Cycle.
- Support internal quality and external regulatory audits and maintain laboratory inspection readiness within the scope of the SDLC.
- Contribute to drafting Standard Operating Procedures (SOPs).
- Originate and own investigations and change management records.
- Contribute to digital innovation activities that improve consistency, compliance, and efficiency.
Benefits
- Medical, dental, and vision healthcare and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
