BIOPHARMACEUTICAL – C&Q Manager

MMR Consulting; Greenville (SC); On-site; USD 120,000 - 180,000; Full time

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

Previous Pharmaceutical/Biotech experience is mandatory for this role.

The work will require working out of client’s facilities, which are in Raleigh, NC, US . Relocation and/or Travel Expense package to Raleigh, NC, US is available for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Automation, Project Management, and Validation CQV.

MMR Consulting has offices in Canada, USA, and Australia Asia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is for C&Q Manager will require to work on the commissioning, qualification & validation of Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…) in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

The work will require working out of client’s facilities, which are in Raleigh, NC, US .

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…) bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and 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 to ensure timely completion and to ensure all specifications are met.
• 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 Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• 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.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 1-3 years for years of experience 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, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Experience with commissioning and qualification of biotech process equipment & systems, including but not limited to some of the following; Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset, but not required.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of 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

Compensation: Based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.