Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process…
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$80k–$100k/yr
Full-time
bachelor degree
Posted 48d ago
~40 hrs/week
Responsibilities
Provide technical guidance for the commissioning, qualification, and start-up of pharmaceutical process equipment and facilities. Lead the development and execution of key qualification deliverables including DQ, FAT, SAT, IQ, OQ, and PQ.
Requirements
Requires an engineering degree and at least 3 years of experience in CQV within the pharmaceutical or biotech industry. Proficiency in risk-based approaches like ASTM E-2500 and experience with cGMP process equipment is essential.
Full job description
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.
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 specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work will require working out of client’s facilities.
The work will require working out of the client’s facilities in Raleigh, North Carolina.
Responsibilities
Provide technical guidance into 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, 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 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
3+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
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 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.
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 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 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 fast-paced environment.
Strong multi-tasking skills
Compensation : 80,000$ - 100,000$ based on industry 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.
MMR Consulting Inc. and its dedicated team of experienced consultants are committed to delivering high quality, robust solutions for the Pharmaceutical and Biotechnology industries. Our expertise includes Engineering (Process, Automation, Facilities), Capital Project Management of large/complex projects and programs, Commissioning Qualification Validation, and GMP Compliance services.
Offices: Loker Ave E, Suite 110, Carlsbad, California 92010, US · 2500 Regency Pkwy, Raleigh, North Carolina, US · 15255 S 94th Ave, 5, Chicago, Illinois 60462, US · 81 Zenway Blvd, 3, Toronto, Ontario L4H 0S5, CA · 171 Clarence St, 10, Australia, New South Wales 2000, AU
Capital Project ManagementCapital Project Controlsand Construction ManagementBiotechnologyManagement ConsultingLife ScienceIndustrial Automation
How much do Engineering jobs in North Carolina pay?
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