Laboratory Process Validation Scientist
Location: Sanford, NC (Fully Onsite)
Contract Length: 4–6 Months
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Start Date: Late June/Early July 2026
Pay Range: $40–70/hr (based on experience)
Position Overview
We are seeking an experienced Laboratory Process Validation Scientist to support the qualification and validation of laboratory instrumentation within a GMP-regulated pharmaceutical environment.
This individual will play a key role in a high-priority validation project involving an Atomic Absorption Spectroscopy (AAS) system used for trace metals and elemental impurities testing.
While direct AAS experience is preferred, candidates with strong laboratory instrument validation, equipment qualification, and Computer System Validation (CSV) experience are encouraged to apply.
The ideal candidate will have hands-on experience supporting validation lifecycle activities, including IQ/OQ/PQ execution, validation documentation, risk assessments, change controls, deviations, and GMP compliance.
Key Responsibilities:
- Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for laboratory instrumentation.
- Support the validation of an Atomic Absorption Spectroscopy (AAS) system used for elemental impurities and trace metals testing.
- Author, review, execute, and maintain validation protocols, reports, traceability matrices, and supporting documentation.
- Ensure equipment is installed, configured, and operating in accordance with site requirements, manufacturer specifications, and regulatory expectations.
- Support validation lifecycle activities including risk assessments, deviations, CAPAs, change controls, and validation summary reporting.
Technical & Cross Functional Support:
- Collaborate with Quality, Engineering, Validation, QC Laboratory, EHS, and vendor teams throughout installation and qualification activities.
- Provide technical support for laboratory instrumentation qualification, troubleshooting, and continuous improvement initiatives.
- Assist with method transfer activities and qualification efforts associated with analytical laboratory equipment.
- Evaluate risks associated with laboratory systems and implement appropriate mitigation strategies.
Safety & Compliance:
- Ensure safe operation and qualification of gas-based analytical instrumentation and related laboratory systems.
- Partner with EHS and Facilities teams to ensure compliance with site safety requirements and operational controls.
- Maintain inspection-ready documentation in accordance with GMP requirements and global regulatory expectations.
- Support data integrity, compliance, and validation best practices throughout the project lifecycle.
Required Qualifications
- Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
- 3+ years of experience supporting equipment validation, qualification, or Computer System Validation (CSV) activities in a regulated environment.
- Demonstrated experience authoring and executing IQ, OQ, and PQ protocols.
- Experience validating laboratory instrumentation within pharmaceutical, biotech, or medical device organizations.
- Strong understanding of GMP regulations, data integrity requirements, and validation lifecycle principles.
- Experience with risk assessments, change controls, deviations, and CAPA processes.
- Ability to independently drive validation activities with minimal supervision.
Preferred Qualifications
- Direct experience with Atomic Absorption Spectroscopy (AAS).
- Experience validating analytical laboratory instruments such as HPLC, GC, ICP-MS, ICP-OES, dissolution systems, spectroscopy platforms, or similar technologies.
- Experience supporting trace metals or elemental impurities testing.
- Familiarity with GAMP 5 and 21 CFR Part 11 requirements.
- Background in CQV (Commissioning, Qualification, and Validation) activities.
- Experience supporting regulatory inspections or audits.
Pay: $40.00 - $60.00 per hour
Application Question(s):
- Do you have a Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
- Do you have Experience validating laboratory instrumentation within pharmaceutical, biotech, or medical device organizations.
- Do you have 3+ years of experience supporting equipment validation, qualification, or Computer System Validation (CSV) activities in a regulated environment.
- Do you have experience authoring and executing IQ, OQ, and PQ protocols.
Work Location: In person
