BIOPHARMACEUTICAL SENIOR VALIDATION SPECIALIST/C&Q ENGINEER

3 weeks ago

NC United States MMR Consulting Full time
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 other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the client's facilities.

This role is for Sr. Validation Specialist role 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/mentor intermediate/junior engineers.

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
  • Lead/Mentor a team of validation engineers/specialists.

Qualifications
  • 12+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
  • Experience with commissioning & qualification of equipment & facilities is required.
  • Aseptic Fill Finish experience is an asset.
  • 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

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.

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