Previous pharmaceutical or biotechnology experience is mandatory.
At least 12 years of experience in commissioning, qualification, or validation of systems in the pharmaceutical or biotechnology industry.
Knowledge of requirements for current Good Manufacturing Practice operations.
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.
An engineering degree is required; Mechanical, Electrical, or Chemical Engineering is preferred.
Ability to handle multiple projects in a fast-paced environment.
Ability to lift 50 pounds.
Ability to work at client facilities and comply with client safety rules, including mandatory COVID-19 vaccination policies where applicable.
Ability to travel occasionally.
Responsibilities
Provide technical guidance in commissioning, qualification, and start-up of pharmaceutical and biopharmaceutical current Good Manufacturing Practice process equipment, utilities, and facilities.
Lead development of qualification deliverables, including writing test cases for Design Qualification, Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, and Performance Qualification, throughout the project lifecycle.
Execute qualification test cases and protocols in the field.
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.
Apply relevant regulatory requirements and industry best practices to process equipment, clean utilities, automation systems, laboratory equipment, buildings, and facilities, as applicable.
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 Tests.
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 and key client relationships, business development, project scheduling and budgeting, coordination of client and company resources, technical sales proposals, and industry presentations or publications as needed.
Supervise contractors during critical testing of systems and equipment.
Lead and mentor a team of validation engineers and specialists.
Perform other duties assigned by the client or company based on workload and project requirements.
Desired Qualifications
Experience with 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 E-2500 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 leading validation teams, managing staff priorities, providing mentorship and oversight, and helping staff resolve issues.
Ability to take initiative and lead projects involving multiple stakeholders, departments, and varying levels of complexity.
Ability to coach and develop junior and intermediate employees.
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 Sr. C&Q 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 in US (company offers TN Visa sponsorship).
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
Lead/Mentor a team of validation engineers/specialists.
Qualifications
12+ 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
Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset but not required.
Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities.
Possess mentorship skills, to coach and develop junior and intermediate employees.
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.
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.