What are the responsibilities and job description for the C&Q Area Lead Process Equipment position at Stellent IT LLC?
Job Details
Title: C&Q Area Lead Process Equipment
Location: Harrisburg, PA | Onsite
Duration: Long term project
Job Description:-
Position Overview
- The Commissioning & Qualification (C&Q) Lead will spearhead end-to-end commissioning, qualification, and validation activities for upstream and downstream bioprocessing equipment in a vaccine manufacturing facility. This role demands technical mastery in qualifying Single Use Technologies (SUT) and critical systems such as buffer preparation skids, homogenizers, UF/DF filtration systems, and biotinylation skids. The ideal candidate will have 10 years of hands-on C&Q experience in biologics/vaccine production, with a proven ability to align equipment validation with FDA/EMA regulations and ICH guidelines.
Key Responsibilities
1. C&Q Strategy & Leadership
- Develop and execute risk-based C&Q plans for upstream/downstream equipment per ASTM E2500, ISPE C&Q Guide, and GAMP 5 frameworks.
- Lead Design Qualification (DQ) to verify equipment designs comply with URS (e.g., scalability, sterility, leachable control for vaccine processes).
- Define acceptance criteria for IQ/OQ/PQ protocols (e.g., mixing accuracy, temperature uniformity, SIP/CIP efficacy) and ensure traceability to process Critical Quality Attributes (CQAs).
2. C&Q Execution
Upstream Equipment
- Buffer/Reagent Preparation Systems: Execute installation qualification (IQ) to verify mechanical/functional installation and material compatibility. Conduct operational qualification (OQ) to validate mixing accuracy, dissolution performance, and temperature control.
- Buffer Aliquoting Systems: Qualify precision of aliquot dispensing and sterility through media fill simulations.
Downstream Equipment
- Homogenizers: Validate cell disruption efficiency and thermal management during high-shear operations.
- UF/DF Skids: Perform IOQ to assess tangential flow filtration (TFF) operational consistency and viral clearance capability.
- Biotinylation Systems: Verify conjugation efficiency and residual reagent removal post-process.
Single Use Technologies (SUT)
- Integrity & Biocompatibility: Qualify SUT components (bags, connectors) using leak detection methods and biological safety testing per pharmacopeia standards.
- Material Safety: Conduct extractable/leachable (E/L) studies to assess compatibility with vaccine intermediates under process conditions.
General Approach
- Align testing with process requirements and regulatory guidelines (e.g., ASTM, USP).
- Use risk-based methodologies to define test scope for critical parameters.
- Document results in lifecycle-appropriate protocols/reports.
3. Compliance & Documentation
Author and approve C&Q lifecycle documents, including:
- Risk Assessments (e.g., FMEA for cross-contamination risks in multi-product facilities).
- Protocols/reports for temperature mapping ( 40 sensors per cold room) and SIP cycles ( 3 consecutive successful runs).
- Ensure compliance with 21 CFR Part 11, EU Annex 11, and FDA Process Validation Guidance (2011) for electronic records (SCADA/MES) and data integrity.
4. Risk Management
- Conduct System Impact Assessments to prioritize validation activities based on product/patient risk.
- Mitigate risks in SUT supply chains by auditing vendors (e.g., Sartorius, Thermo Fisher) and qualifying alternative materials.
Qualifications
- Education: BS/MS in Chemical Engineering, Bioprocessing, or related field.
Experience:
- 10 years in C&Q leadership roles for vaccine/biologics facilities, including hands-on work with:
- Upstream: Media/buffer systems, perfusion bioreactors ( 2,000L).
- Downstream: Chromatography (A KTA), viral filtration, TFF skids.
- Expertise in Filling line (Bottles) and aseptic processing (ISO 5/7 environments).
Technical Skills:
- Proficiency in DeltaV, Kneat, or ValGenesis for electronic validation workflows.
- Advanced knowledge of SUT ASTM standards (e.g., F1980 for irradiation validation).
- Certifications: PMP, ISPE C&Q Professional, or ASQ CQE preferred.
Preferred Expertise
- Experience qualifying continuous processing systems (e.g., CaptureSMB chromatography).
- Familiarity with ATEX directives for hazardous area classifications in solvent-based processes.
Best regards,
Lavesh Kumar
| Sr. Technical Recruiter
STELLENT IT A Nationally Recognized Minority
Certified Enterprise
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