Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning and Qualification Specialist – Process Equipment (Syringe Filling Lines)

Position Summary

The Commissioning and Qualification (C&Q) Specialist for Process Equipment will lead and execute the commissioning and qualification activities for syringe filling lines in a regulated GMP environment. The role requires expertise in process equipment validation, including filling, stoppering, sealing, and inspection systems. The C&Q Specialist ensures compliance with industry regulations, quality standards, and project timelines while collaborating with cross-functional teams to support new installations, upgrades, and lifecycle management.

Key Responsibilities

1. Commissioning Activities

• Develop and execute commissioning protocols for syringe filling lines and associated equipment (e.g., isolators, conveyors, filling pumps, and inspection systems).
• Perform factory acceptance testing (FAT), site acceptance testing (SAT), and start-up activities to ensure equipment functionality and performance.
• Identify and resolve technical issues encountered during commissioning.

2. Qualification & Validation

• Author, review, and execute qualification protocols (IQ, OQ, PQ) for syringe filling lines and auxiliary equipment.
• Perform critical parameter testing, including aseptic filling process validation, media fills, and sealing integrity testing.
• Conduct risk assessments and ensure qualification aligns with regulatory and quality requirements.

3. Documentation

• Develop and maintain all C&Q documentation, including protocols, reports, and supporting data.
• Ensure accurate traceability and alignment with the validation master plan (VMP).
• Document and manage deviations, CAPAs, and change control processes related to process equipment.

4. Compliance and Regulatory Adherence

• Ensure all activities comply with regulatory requirements, including FDA, EMA, and ISO standards.
• Support data integrity initiatives and compliance with 21 CFR Part 11 and Annex 11 for computerized systems.
• Prepare for and support regulatory audits and inspections.

5. Lifecycle Management

• Oversee equipment requalification, periodic reviews, and performance monitoring.
• Support decommissioning activities for obsolete equipment while maintaining documentation records.
• Partner with maintenance and engineering teams for equipment calibration and troubleshooting.

6. Cross-Functional Collaboration

• Collaborate with manufacturing, engineering, quality assurance, and validation teams during project execution.
• Work closely with equipment vendors to ensure timely delivery, setup, and qualification.
• Act as a subject matter expert (SME) for syringe filling line operations and qualification during audits.

7. Training

• Train operators and technicians on proper use and maintenance of qualified process equipment.

Qualifications:

Education

• Bachelor’s degree in Engineering (Mechanical, Chemical, or Industrial), Biotechnology, or a related technical field.

Experience

• 5+ years of experience in commissioning, qualification, and validation of process equipment in pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience with syringe filling equipment, isolators, and automated systems.
• Familiarity with aseptic processing and sterile manufacturing principles.

Skills

• Strong technical writing skills for protocol development and report generation.
• Proficient in process risk assessment tools (e.g., FMEA, HAZOP).
• Strong project management and organizational skills.
• Effective communication and problem-solving abilities for cross-functional collaboration.

Knowledge

• In-depth knowledge of GMP, FDA, EMA, and ISO 13485 regulations.
• Familiarity with process validation principles (e.g., ICH Q8/Q9/Q10).
• Experience with equipment automation systems and SCADA platforms.

Preferred Qualifications

• Certification in C&Q, validation, or process engineering (e.g., ISPE, PDA).
• Experience with automated visual inspection and serialization systems.
• Knowledge of Lean Manufacturing or Six Sigma methodologies.

Working Conditions

• Manufacturing plant environment.
• Flexibility to work extended hours or weekends during critical project phases.
• Occasional travel to vendor facilities for FATs or training.