Two to four years of experience in commissioning, qualification, or validation of systems within the pharmaceutical or biotechnology industry.
Previous experience in the pharmaceutical or biotechnology industry, with knowledge of requirements for current good manufacturing practice operations.
Knowledge of relevant regulatory requirements and industry best practices for process equipment, clean utilities, automation systems, laboratory equipment, buildings, and facilities.
An engineering degree, preferably in Mechanical, Electrical, or Chemical Engineering.
Ability to handle multiple projects in a fast-paced environment.
Strong multitasking skills.
Ability to lift 50 pounds.
Ability to travel occasionally.
Compliance with client safety rules, including mandatory COVID-19 vaccination policies where applicable.
Responsibilities
Provide technical guidance in the commissioning, qualification, and start-up of pharmaceutical and biopharmaceutical current good manufacturing practice process equipment, utilities, and facilities.
Lead the development of key qualification deliverables, including design qualification, factory acceptance testing, site acceptance testing, installation qualification, operational qualification, and performance qualification, throughout the project lifecycle.
Perform field execution of qualification test cases and protocols.
Support development of Project Validation Plans to ensure the system testing action plan is applicable and relevant.
Lead qualification processes throughout the project lifecycle to ensure timely completion and compliance with quality and engineering specifications.
Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
Engage other departments in design reviews and decisions as required.
Travel occasionally for meetings with equipment fabrication vendors or factory acceptance testing.
Provide occasional support during shutdowns or extended hours, particularly during installation, construction, commissioning, qualification, and validation phases.
Visit construction and installation sites while wearing required safety personal protective equipment.
Support client management by maintaining key client relationships for business development and pursuing new work.
Support project scheduling and budgeting and coordinate client and company resources for effective project delivery.
Provide technical support to sales for proposals and business-development opportunities.
Present at industry conferences and publish papers as applicable.
Supervise contractors during critical system and equipment testing.
Perform other duties assigned by the client or company based on workload and project requirements.
Desired Qualifications
Validation experience, including cleaning validation, thermal validation, mixing studies, process validation, or computer systems validation.
Experience developing and executing validation projects using 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, as well as building automation systems.
Experience commissioning and qualifying biotechnology process equipment such as fermentation systems, bioreactors, downstream purification processes including chromatography, tangential flow filtration, and ultrafiltration, clean-in-place systems, buffer systems, and clean utilities.
Experience qualifying or validating clean utilities and ISO clean rooms.
Experience preparing and executing user requirements specifications, design qualifications, requirements traceability matrices, risk assessments, critical process parameters, validation project plans, factory acceptance tests, site acceptance tests, and installation/operational qualifications.
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.
This role is for Jr. CQV Engineer 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 typically in the Greater Denver/Boulder Colorado & surrounding areas.
Responsibilities
Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
Able to perform field execution of qualification test cases and protocols.
Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, and provide updates.
Engage other departments, as required, in the design reviews and decisions.
Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification, and validation phases.
Visit construction and installation sites, wearing necessary safety PPE.
You may be involved with other aspects such as 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.
Supervise contractors during critical testing of system and equipment.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable
Qualifications
2-4 years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
Experience with commissioning and qualifications of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
Experience with Qualification or Validation of clean utilities and ISO clean rooms.
Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
Engineering degree, preferably in Mechanical, Electrical or Chemical.
Travel may be required on occasion.
Ability to handle multiple projects and work in a fast-paced environment.
Strong multi-tasking skills
Ability to lift 50 lbs.
Compensation: 80,000$ - 115,000$ based on experience.
As part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.
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.