Previous pharmaceutical or biotechnology experience is mandatory.
At least 8 years of experience in commissioning, qualification, or validation of systems within the pharmaceutical or biotechnology industry.
Knowledge of cGMP operations requirements, including standard operating procedures, change controls, and validation.
Experience commissioning and qualifying biotechnology process equipment, including upstream or downstream processes such as fermentation, bioreactors, chromatography, and tangential flow filtration or ultrafiltration.
Experience preparing and executing user requirement specifications, design qualifications, requirements traceability matrices, risk assessments, critical process parameters, validation project plans, factory acceptance tests, site acceptance tests, installation/operational qualifications, nonconformance reports, and final reports.
Ability to lift 50 pounds.
A science degree or equivalent studies in Mechanical, Electrical, Chemical, Biochemical, or Electromechanical disciplines, or a related discipline, together with industry experience.
Ability to handle multiple projects in a fast-paced environment.
Ability to prepare technical documents in English and communicate effectively in spoken and written English.
Responsibilities
Provide technical guidance for commissioning, qualification, and start-up of equipment and facilities used in life science manufacturing, including bioreactors, tanks, clean-in-place systems, buffers, media, chromatography systems, tangential flow filtration systems, washers, and autoclaves.
Lead development of key qualification deliverables throughout the project lifecycle to define projects and ensure system test plans are applicable and relevant.
Lead qualification processes throughout the project lifecycle, including validation project plans, risk assessments, requirements traceability matrices, design qualification, factory acceptance testing, site acceptance testing, installation qualification, operational qualification, and performance qualification, as appropriate.
Prepare and execute protocols, summarize data, resolve deviations, and prepare final reports.
Coordinate meetings with cross-functional departments to advance project progress, facilitate decisions, and provide updates.
Engage other departments in design reviews and decision-making as required.
Travel occasionally to client meetings, equipment fabrication vendors, or factory acceptance tests.
Provide occasional support during shutdowns or extended hours, particularly during installation, commissioning, and validation phases.
Maintain key client relationships in support of business development and pursuit of new work; manage project scheduling and budgeting; coordinate client and company resources for project delivery; support business development and proposals with technical input; and present at industry conferences or publish papers.
Visit construction and installation sites while following site safety requirements.
Perform other duties assigned by the client or company based on workload and project requirements.
Desired Qualifications
Experience commissioning and qualifying other process equipment, utilities, or facilities.
Experience with thermal validation.
Experience applying risk-based commissioning and qualification approaches, such as ASTM E2500 or ISPE ICQ.
Experience commissioning and qualifying process control systems, including process control systems, supervisory control and data acquisition, and historians, and building automation systems such as Siemens Insight, Siemens Desigo, or Johnson Controls Metasys.
Experience qualifying or validating clean utilities and ISO clean rooms.
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.
MMR Consulting has offices in Canada, USA, and Australia.
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 validation of upstream and downstream bioprocess systems/equipment 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 US (company offers TN Visa sponsorship).
Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as 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.
Experience with C&Q of upstream or downstream bioprocess 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: 8+ 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 (upstream or downstream or both), 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
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.