Specialist, Global Analytical Instrument Validation; On-site

The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities and Operations (ACO) department of our Research & Development Division is seeking applicants for a Validation Specialist position available at the West Point research facility.

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 laboratory environment for multiple sites (Pennsylvania, New Jersey, and Schachen, CH).

• Partner with scientific teams across DSCS to drive compliance and operational excellence.
• Validate novel and time-sensitive instrumentation in GMP environments to 21
  
  CFR
  11 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.

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.

• Bachelor's degree, or higher, in analytical science, information technology 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, including applications of/for Artificial Intelligence (AI).
• 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.

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

• 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.

• Analytical Instrumentation
• Analytical Laboratory Equipment
• Computer System Validation (CSV)
• Data Analysis
• Equipment Maintenance
• Experimentation
• GMP Environments
• GMP Laboratory
• Inventory Management
• Regulatory Compliance
• Standard Operating Procedure (SOP) Writing

Metrology

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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