Lab Validation Lead

Piper Companies; Marietta (PA); On-site; USD 55,000 - 83,000; Full time

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 located in Marietta, PA. The Lab Validation Lead will lead equipment qualification, analytical instrument validation, calibration programs, and computerized system validation efforts while partnering with quality, laboratory, engineering, IT, and global validation teams.

Responsibilities of the Lab Validation Lead:

• 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.

Qualifications of the Lab Validation Lead:

• Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
• 5+ years of pharmaceutical, biotech, or vaccine industry experience.
• Experience supporting QC laboratory validation rather than manufacturing or production validation.
• Hands-on experience with analytical laboratory instruments such as HPLC, GC, and related systems.
• Strong experience writing and executing IQ/OQ/PQ protocols and validation documentation.
• Knowledge of cGMP, GxP, FDA regulations, computerized system validation, and data integrity requirements.
• Experience supporting audits, inspections, and vendor management activities.
• Strong communication skills with the ability to lead meetings and work across multiple stakeholder groups.
• Positive attitude, strong ownership mentality, and ability to work independently.

Compensation for the Lab Validation Lead includes:

• Salary range: 40/hr-60/hr (flexible based on experience)
• 5 days on-site per week
• Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
• Career growth opportunities within a global pharmaceutical organization

Keywords: Lab Validation, Laboratory Validation, QC Validation, Quality Control Laboratory, Analytical Chemistry, Biochemistry, Pharmaceutical Validation, Biopharmaceutical Validation, Vaccine Manufacturing, GMP, cGMP, GxP, IQ/OQ/PQ, Equipment Qualification, Laboratory Equipment Validation, Computer System Validation (CSV), Data Integrity, Calibration, Requalification, Lifecycle Management, HPLC, GC, Gas Chromatography, Liquid Chromatography, Analytical Instrumentation, Laboratory Systems, LIMS, Laboratory Execution Systems (LES), Change Control, CAPA, Deviations, Risk Assessments, Validation Master Plan (VMP), User Requirements Specifications (URS), FDA Regulations, Audit Readiness, Regulatory Compliance, Vendor Management, Laboratory Automation, QC Operations, Instrument Qualification, Validation Lead, Technical Writing, Cross-Functional Leadership, Pharmaceutical Quality Systems.

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