Biopharma C&Q Manager: Upstream Systems Lead

MMR CONSULTING

Atlanta (GA)

On-site

USD 90,000 - 150,000

Full time

3 days ago

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Job summary

MMR Consulting is seeking an experienced C&Q Manager to lead commissioning, qualification, and validation of Upstream Bioprocess Equipment and process systems for biopharmaceutical applications. You will work from client facilities in Raleigh, NC, with relocation/travel support as needed.

The successful candidate has 5+ years in pharma/biotech validation, strong English skills, and a track record of delivering GMP-compliant qualification deliverables while coordinating multi-disciplinary teams

Qualifications

Excellent written and spoken English is required.
Years of experience: 5+ years in commissioning, qualification or validation of systems in pharma/biotech.
Knowledge of cGMP operations, including SOPs, Change Controls, Validation.
Experience with developing and executing validation projects using Risk-Based approaches (e.g., ASTM E-2500/ISPE ICQ).
Experience with commissioning and qualification of biotech process equipment & systems (Upstream Bioprocess Equipment, fermentation, bioreactors, downstream purification etc.).
Experience with commissioning & qualification of process control systems (PCS/SCADA) and building automation systems is an asset.
Experience with Qualification or 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 manufacturing equipment and facilities.
Lead development of key qualification deliverables to ensure project scope and test plans are aligned.
Lead qualification processes (VPP, Risk Assessments, RTMs, DQ, FAT, IQ/OQ/PQ) to ensure timely completion.
Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports.
Travel may be required for meetings with clients, vendors, or FATs.
Coordinate meetings with cross-functional departments to drive project progress and decisions.
Visit construction and installation sites following site safety requirements.
Engage other departments for design reviews and decisions.
Provide technical support for proposals/opportunities and industry communications.