Lead CQV Specialist - Biopharma Systems Validation

MMR CONSULTING; North Carolina; On-site; USD 140,000 - 190,000; Full time

Job summary

MMR Consulting is seeking a Lead CQV Specialist to validate upstream/downstream bioprocess systems and process equipment in pharma/biotech settings. The role requires leadership to guide intermediate and junior specialists, and will involve working at client facilities in the Raleigh-Durham-Chapel Hill region.

Responsibilities include steering commissioning/qualification across DQ to PQ, developing PVPs, coordinating with cross-functional teams, and mentoring a team of validation staff.

Qualifications

• 12+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
• Experience with commissioning & qualification of equipment & facilities is required.
• Regulatory knowledge andRisk-based approaches (e.g., ASTM E-2500 / ISPE ICQ) are relevant assets.

Responsibilities

• Provide guidance into commissioning, qualification and startup of pharma/biopharma equipment, utilities & facilities.
• Lead development of key qualification deliverables (DQ, FAT, SAT, IQ, OQ, PQ) during project lifecycle.
• Lead qualification processes to ensure timely completion and that specifications are met.
• Coordinate cross-functional meetings to drive project progress and decisions.
• Mentor junior staff and supervise validation activities on client sites.

Skills

Leadership

Mentorship

Team leadership

Cross-functional

Education

Bachelor's in Mechanical/Electrical/Chemical/Science

Tools

PCS

SCADA

Historians

Building automation

Job description

MMR Consulting is seeking a Lead CQV Specialist to validate upstream/downstream bioprocess systems and process equipment in pharma/biotech settings. The role requires leadership to guide intermediate and junior specialists, and will involve working at client facilities in the Raleigh-Durham-Chapel Hill region.

Responsibilities include steering commissioning/qualification across DQ to PQ, developing PVPs, coordinating with cross-functional teams, and mentoring a team of validation staff.