CQV/QAV Consultant

Stark Pharma Solutions Inc; Wayne (PA); On-site; USD 120,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an experienced CQV/QAV Consultant with 9+ years of hands-on aseptic fill/finish validation in pharma/biopharma manufacturing. You will support commissioning, qualification, and validation activities, and coordinate with multiple functions to ensure GMP/cGMP compliance.

The role requires strong IQ/OQ/PQ execution, rigorous documentation, and teamwork. This is a long-term, on-site opportunity in Wayne, PA, with emphasis on quality, reliability, and

Qualifications

• 9+ years of CQV/QAV/Validation experience in pharma or biopharma.
• Hands-on aseptic fill/finish experience on manufacturing lines.
• Proficient in IQ/OQ/PQ and sterile filling equipment.
• GMP/cGMP knowledge and QA documentation experience.
• Strong communication and teamwork skills.

Responsibilities

• Support commissioning, qualification, and validation activities for aseptic fill/finish systems.
• Execute and review IQ/OQ/PQ protocols and reports.
• Support qualification of filling lines and sterile manufacturing equipment.
• Coordinate with aseptic filling, isolators/RABS, lyophilizers, autoclaves, and related equipment.
• Assist startup, troubleshooting, and validation activities.
• Prepare and review validation documentation.
• Assist deviations, change controls, CAPA, and investigations.
• Collaborate with Engineering, Quality, Manufacturing, and Validation teams.
• Ensure activities comply with GMP/cGMP requirements.

Skills

CQV/QAV validation

Aseptic fill/finish

IQ/OQ/PQ execution

GMP/cGMP compliance

Documentation & troubleshooting

Cross-functional collaboration

Job description

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position:

CQV/QAV Consultant

Location:

Wayne, PA

Duration:

Long Term

Job Overview

We are seeking an experienced CQV/QAV Consultant with 9+ years of experience, including strong hands‑on experience with aseptic fill/finish lines in pharmaceutical or biopharmaceutical manufacturing environments.

Key Responsibilities

• Support commissioning, qualification, and validation activities for aseptic fill/finish systems.
• Execute and review IQ/OQ/PQ protocols and reports.
• Support qualification of filling lines and sterile manufacturing equipment.
• Work with aseptic filling, isolators/RABS, lyophilizers, autoclaves, and related equipment.
• Support equipment startup, troubleshooting, and validation activities.
• Prepare and review validation documentation.
• Support deviations, change controls, CAPA, and investigation activities.
• Work with Engineering, Quality, Manufacturing, and Validation teams.
• Ensure activities comply with GMP/cGMP requirements.

Required Qualifications

• 9+ years of relevant CQV/QAV/Validation experience.
• Strong hands‑on experience with aseptic fill/finish lines.
• Experience in pharmaceutical or biopharmaceutical manufacturing.
• Strong experience with IQ/OQ/PQ.
• Experience with sterile filling and manufacturing equipment.
• Knowledge of GMP/cGMP requirements.
• Experience with commissioning, qualification, and validation.
• Strong documentation and troubleshooting skills.
• Good communication and teamwork skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.