Specialist, Global Analytical Instrument Validation Specialist

Job Description

The Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey or West Point, PA 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 AR&D network. The Analytical Instrument Validation Specialist role oversees and supports the validation of computerized analytical instrumentation within the GMP environment for multiple US-based sites in Pennsylvania and New Jersey.

The key responsibilities of this role will include:

• Partner with scientific teams across AR&D 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 and external quality 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

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 or related field with 3+ years post-degree relevant industry experience.

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 computerized equipment or instrument validation
  • 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 with IT, computerized systems, software and applications, including Secure Desktop
• 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

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