Biopharma C&Q Manager: Upstream Equipment Lead

MMR Consulting; Birmingham (AL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation package

Travel expense assistance

Job summary

MMR Consulting is seeking a C&Q Manager to lead commissioning, qualification, and validation activities for upstream bioprocess equipment and related pharma/biotech process systems at client facilities in Raleigh, NC. The role requires leadership to guide intermediate and junior engineers and coordination across cross-functional teams.

Relocation/travel expense package to Raleigh is available. Prior pharma/biotech C&Q experience and strong English communication are essential, with flexibility

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• 1-3 years of experience in commissioning, qualification or validation in 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) is considered an asset
• Experience with commissioning and qualification of biotech process equipment & systems, including Upstream Bioprocess Equipment (Bioreactors, Fermentation, Centrifugation)
• Experience with commissioning & qualification of process control systems (PCS, SCADA, Historians) and building automation systems (Siemens Insight / Desigo, JCI Metasys)
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation
• Experience with URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports
• Ability to lift 50 lbs
• Science degree, or equivalent studies such as Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline along with industry experience
• Ability to handle multiple projects and work in a fast-paced environment
• Strong multi-tasking skills

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing (Upstream Bioprocess Equipment, bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers, autoclaves)
• Lead the development of key qualification deliverables during the project lifecycle to ensure the action plan to test the system is applicable and relevant
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports
• Experience with C&Q of Upstream Bioprocess Equipment systems is required
• Experience with C&Q of other process equipment, utilities, facilities is an asset
• Thermal Validation experience is an asset
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates
• Engage other departments, as required, for design reviews and decisions
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or FATs
• Work may require occasional support over shutdowns or extended hours during installation and commissioning/validation phases
• Client-management, project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development, presenting at industry conferences/publishing papers
• Visit construction and installation sites following all site safety requirements
• Other duties as assigned by client, and/or MMR, based on workload and project requirements

Skills

Leadership

Multi-tasking

English proficiency

Team coordination

Communication

Physical lifting

Education

Science degree or equivalent

Tools

PCS

SCADA

Historians

Siemens Insight

Desigo

JCI Metasys

Job description

MMR Consulting is seeking a C&Q Manager to lead commissioning, qualification, and validation activities for upstream bioprocess equipment and related pharma/biotech process systems at client facilities in Raleigh, NC. The role requires leadership to guide intermediate and junior engineers and coordination across cross-functional teams.

Relocation/travel expense package to Raleigh is available. Prior pharma/biotech C&Q experience and strong English communication are essential, with flexibility