Biopharmaceutical CQV SPECIALIST

MMR Consulting • Raleigh, NC

4d • $80,000 - $100,000 • Onsite

About The Position

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. 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 the client’s facilities in Raleigh, North Carolina.

Requirements

• Previous Pharmaceutical/Biotech experience is mandatory for this role.
• 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.
• Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ.
• Preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs.
• 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.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Nice To Haves

• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is 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 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.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.

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.

Benefits

• Compensation : 80,000$ - 100,000$ based on industry experience.
• Equal Employment Opportunity and Reasonable Accommodations
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior