Biopharma C&Q Lead: Upstream Equipment & Validation

MMR Consulting

Greenville (SC)

On-site

USD 120,000 - 180,000

Full time

2 days ago
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Job summary

MMR Consulting is seeking a C&Q Manager to lead commissioning, qualification, and validation of upstream bioprocess equipment and related process equipment in pharma/biotech. The role involves working at client facilities, leading teams of intermediate and junior engineers, and occasionally traveling to client sites in Raleigh, NC.

The ideal candidate will have strong leadership, extensive experience in CI&Q activities, and a background in life sciences engineering.

Qualifications

  • 1–3 years in commissioning, qualification or validation in pharma/biotech.
  • Knowledge of cGMP operations, SOPs, Change Controls, Validation.
  • Experience with validation projects and risk-based commissioning approaches (ASTM E-2500 or ISPE ICQ) is a plus.
  • Ability to lift 50 lbs.

Responsibilities

  • Lead qualification deliverables across the project lifecycle to ensure a well-defined action plan and tested system.
  • Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports.
  • Coordinate meetings with cross-functional departments to drive project progress and decisions.
  • Engage other departments for design reviews and decisions.

Skills

English proficiency
Project leadership
Communication skills
Multi-tasking

Education

Science degree
Engineering degree

Tools

PCS
SCADA
Historians

Job description

MMR Consulting is seeking a C&Q Manager to lead commissioning, qualification, and validation of upstream bioprocess equipment and related process equipment in pharma/biotech. The role involves working at client facilities, leading teams of intermediate and junior engineers, and occasionally traveling to client sites in Raleigh, NC.

The ideal candidate will have strong leadership, extensive experience in CI&Q activities, and a background in life sciences engineering.

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