Instrument Validation Specialist

3 weeks ago

Lansdale, United States Kaygen Full time

KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

Job Title: Instrument Validation Specialist
Location: West Point, PA
Duration: 6 months

Job Description:
This will be within the client's quality control labs in their manufacturing division. Need someone that has worked in GMP/GxP environments, hands-on lab equipment validation experience, and lab/QC system implementation experience. Need someone with strong communication skills so they can work independently with key stakeholders. Role is through the end of the year with a possible extension. Candidates MUST be local to the West Point, PA area - the team is requiring this individual to be onsite some days out of the week (hybrid schedule). No set amount of days, just depends on the work (some weeks could be 1 day, some weeks could be 4).

Roles and Responsibilities:
We currently have a contract opportunity for an Instrument Validation Specialist - Contractor to assist our client with the validation of their laboratory equipment through a hybrid work schedule.

  • Develop, review, and execute validation protocols for laboratory instruments, including qualification activities such as IQ (Installation Qualification), OQ(Operational Qualification), and PQ (Performance Qualification) within the manufacturing division of the client.
  • Monitor and assess the performance of pharmaceutical instruments within Quality Control Labs, as well as conduct re-validation or calibration to maintain instrument integrity over its lifecycle.
  • Collaborate with cross-functional teams including laboratory personnel, equipment vendors, and engineering staff to ensure proper implementation of validation activities.
  • Ensure ongoing compliance with GxP/GMP(Good Manufacturing Practices), GLP(Good Laboratory Practices), and other applicable regulations.
  • Maintain detailed and organized documentation for all validation activities, including validation plans, test results, and final reports.
Requirements:
** Candidates must be relatively local to West Point, PA in order to be considered - this position will likely require multiples days of on-site work each week. **
  • Minimum of 5+ years of experience in an Instrument Validation role within a healthcare, pharmaceutical, or other related industries.
  • Expert knowledge of validation principles, regulatory standards, and industry guidelines for instrument validation.
  • Excellent organizational skills with the proven ability to work independently.
  • Proficiency in written and verbal communication, with the ability to produce clear and detailed validation documentation.
  • Ability to identify opportunities for process improvements and participate in the implementation of quality improvement initiatives by working closely with key stakeholders.
At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at www.kaygen.com.

Benefits:
  • Free Healthcare Insurance
  • Vision and Dental Insurance
  • 401(k) Retirement Plan
  • Free Life Insurance
  • Sick Time Off
Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:Certifications
  • Mentorship Program
  • Referrals
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