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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 CQV Process Engineering and Automation services. MMR covers the full life science spectrum including Oral Solid Dosage SemiSolids LiquidDosage (TS and Aseptic) API manufacturing Biotechnology (Vaccines Blood Plasma Fractions Monoclonal Antibodies Cell & Gene Therapy mRNA etc..
MMRConsulting hasofficesinCanadaUSAandAustralia.
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 startup and project management of various processes systems and ideal candidate should possess leadership skills to lead teams of intermediate & junior work may require working out of clients facilities which are typically in theGreater Denver/Boulder Colorado & surrounding areas.
The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
Responsibilities
Lead large CQV projects from inception through to full doc prep and closure
Setup the CQV Strategy and CQV plans for large expansion projects including resources org chart deliverables schedule
Drive CQV projects through to completion
Provide technical expertise in at least one workstream (Upstream Downstream Clean Utils Utilities Laboratories Automation)
Experience with ASTM E2500 and ISPE Integrated C&Q approaches
Provide technical guidance in the commissioning qualification and startup 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 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 crossfunctional departments to drive project progress facilitate decisions provide updates.
Engage other departments as required into 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 clientmanagement (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.
Lead/Mentor a team of validation engineers/specialists.
Supervise contractors during critical testing of system and equipment.
Other duties as assigned by client and/or MMR based on workload and project requirements.
Qualifications
7 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.
Experience with commissioning & qualification of equipment & facilities is required.
Validation experience such as cleaning validation thermal validation mixing studies process validation computer systems validation is preferred.
Experience with developing and executing validation projects to RiskBased Commissioning & Qualification approaches such as ASTM E2500 or ISPE ICQ is considered an asset.
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 qualification 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 of URSs DQs 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 complexity.
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 fastpaced environment.
Strong multitasking 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.
Required Experience:
Manager
Full-Time