Biopharma C&Q Manager - Upstream Process Equipment

MMR CONSULTING; Birmingham (AL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Travel assistance

Job summary

MMR Consulting is seeking an experienced C&Q Manager to lead commissioning, qualification, and validation of upstream bioprocess equipment for biopharma projects. The role will involve working at client facilities in Raleigh, NC, with travel/relocation support.

You will guide cross-functional teams, develop qualification deliverables, ensure cGMP compliance, and manage project schedules and budgets while interfacing with engineering and operations.

Qualifications

• 5+ years in commissioning, qualification, or validation in pharma/biotech.
• Strong knowledge of cGMP requirements and SOPs.
• Experience with risk-based commissioning/qualification approaches such as ASTM E-2500 or ISPE ICQ is a plus.
• Experience with biotech process equipment (upstream bioprocess, bioreactors, fermentation, chromatography, TFF).
• Experience with process control systems and building automation assets is a plus.
• Ability to lift 50 lbs and work in a fast-paced environment.
• Excellent written and spoken English.

Responsibilities

• Provide technical guidance on commissioning, qualification, and start-up of life science equipment.
• Lead development of qualification deliverables across project lifecycle.
• Coordinate cross-functional meetings to drive project progress and decisions.
• Engage other departments for design reviews and approvals.
• Travel may be required for meetings, FATs, or vendor activities.
• Visit construction/installation sites following safety requirements.

Skills

C&Q Bioprocess

Leadership

Project management

English communication

Education

Science degree or related discipline

Tools

PCS/SCADA

Siemens Insight/Desigo

JCI Metasys

Job description

MMR Consulting is seeking an experienced C&Q Manager to lead commissioning, qualification, and validation of upstream bioprocess equipment for biopharma projects. The role will involve working at client facilities in Raleigh, NC, with travel/relocation support.

You will guide cross-functional teams, develop qualification deliverables, ensure cGMP compliance, and manage project schedules and budgets while interfacing with engineering and operations.