QC Lab Validation Lead — Instrumentation & CSV Expert

Piper Companies

Marietta (PA)

On-site

USD 55,000 - 83,000

Full time

4 days ago
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Benefits offered by this job

Medical, dental, vision insurance
401(k)
PTO
Career growth opportunities

Job summary

Piper Companies is seeking a Lab Validation Lead to support QC laboratory validation activities for a leading pharmaceutical and vaccine manufacturer in Marietta, PA. The role leads qualification of equipment and analytical instruments (HPLC, GC, balances) and manages IQ/OQ/PQ protocols, validation documentation, and lifecycle management.

Collaborating with quality, engineering, IT, and global validation teams, you will ensure cGMP compliance and data integrity while training staff and driving

Qualifications

  • Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline.
  • 5+ years of pharmaceutical, biotech, or vaccine industry experience.
  • Hands-on with QC laboratory instruments such as HPLC, GC, and related systems.
  • Strong experience writing IQ/OQ/PQ protocols and validation documentation.
  • Knowledge of cGMP, GxP, FDA regulations, and data integrity requirements.
  • Experience supporting audits, inspections, and vendor management activities.

Responsibilities

  • Lead validation lifecycle activities for QC laboratory equipment and systems.
  • Author, execute, and review IQ/OQ/PQ protocols, reports, and validation documentation.
  • Support qualification and lifecycle management of analytical instruments including HPLC, GC, balances, and environmental chambers.
  • Manage calibration, maintenance, requalification, and vendor-supported services.
  • Support computerized system validation, data integrity, access controls, and change management activities.
  • Lead investigations, deviations, CAPAs, and audit readiness efforts.
  • Partner with QC, Quality, Engineering, IT, and global validation teams to maintain compliance and operational excellence.
  • Train personnel and provide technical leadership for validation activities.

Skills

IQ/OQ/PQ protocols
HPLC
GxP
FDA regulations
Data integrity
Cross-functional leadership
Validation documentation
Audit readiness
Vendor management
Calibration
LIMS
CSV

Education

Bachelor's degree in Chemistry/ Biology/ Engineering

Tools

HPLC
GC
Balances
Environmental chambers
LIMS
LES
CSV

Job description

Piper Companies is seeking a Lab Validation Lead to support QC laboratory validation activities for a leading pharmaceutical and vaccine manufacturer in Marietta, PA. The role leads qualification of equipment and analytical instruments (HPLC, GC, balances) and manages IQ/OQ/PQ protocols, validation documentation, and lifecycle management.

Collaborating with quality, engineering, IT, and global validation teams, you will ensure cGMP compliance and data integrity while training staff and driving

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