Biopharma C&Q Lead: Upstream Equipment Validation

MMR CONSULTING; Chattanooga (TN); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Travel expense package

Job summary

MMR Consulting is seeking a C&Q Manager to lead commissioning, qualification, and validation of upstream bioprocess equipment and related process systems for pharma/biotech clients. You will oversee CGI deliverables, coordinate cross-functional teams, and ensure project success at client sites in Raleigh, NC.

The ideal candidate has 5+ years in commissioning/qualification/validation within pharma/biotech, strong leadership, and experience with GMP, IQ/OQ/PQ, and risk-based approaches.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 5+ years in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation
• Experience with developing and executing validation projects; Risk-Based Commissioning & Qualification approaches (ASTM E-2500 or ISPE ICQ) viewed as asset
• Experience with commissioning and qualification of biotech process equipment & systems (upstream bioprocess equipment, fermentation, bioreactors, downstream purification) is required
• Experience with process control systems (PCS/SCADA) and building automation systems (Siemens Insight/Desigo, JCI Metasys) is an asset
• Experience with qualification/validation of clean utilities, ISO clean rooms, and Thermal Validation is an asset
• Experience with URS, DQ, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports
• Ability to lift 50 lbs
• Science degree or related discipline with industry experience
• Ability to handle multiple projects in a fast-paced environment
• Strong multi-tasking skills

Responsibilities

• Provide technical guidance into commissioning, qualification and start-up of life science equipment and facilities (upstream bioprocess equipment, bioreactors, CIP, buffers, media, chromatographic steps)
• Lead development of key qualification deliverables throughout the project lifecycle
• Oversee qualification activities (VPP, risk assessments, RTMs, DQ, FAT, SAT, IQ, OQ, PQ) to ensure timely completion
• Prepare and execute protocols, summarize data, resolve deviations, prepare final reports
• Coordinate cross-functional meetings to drive project progress and decisions
• Engage departments for design reviews and decisions
• Travel as needed for client meetings, FATs, vendors
• Support business development and client relationship activities

Skills

C&Q

Bioprocess equipment

Project management

IQ/OQ/PQ

Risk assessments

Leadership

Multitasking

English proficiency

Education

Science degree or related discipline

Tools

PCS/SCADA

Siemens Insight/Desigo

JCI Metasys

Job description

MMR Consulting is seeking a C&Q Manager to lead commissioning, qualification, and validation of upstream bioprocess equipment and related process systems for pharma/biotech clients. You will oversee CGI deliverables, coordinate cross-functional teams, and ensure project success at client sites in Raleigh, NC.

The ideal candidate has 5+ years in commissioning/qualification/validation within pharma/biotech, strong leadership, and experience with GMP, IQ/OQ/PQ, and risk-based approaches.