CQV / Validation Engineer – Pharmaceutical

MMR CONSULTING; Greenville (SC); On-site; USD 90,000 - 120,000; Full time

Job summary

MMR Consulting in Augusta, GA seeks a senior Validation Engineer to lead commissioning, qualification and start-up of cGMP process equipment, utilities and facilities. You will guide field execution, coordinate cross-functional teams, and ensure adherence to regulatory and client requirements.

You will develop and review DQ, FAT, IQ, OQ and PQ deliverables, mentor junior staff, and support project validation plans.

Qualifications

• 5+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Experience with commissioning & qualification of equipment & facilities.
• Background in cGMP operations.
• Experience with Risk-Based Commissioning & Qualification approaches (e.g., ASTM E-2500 or ISPE ICQ).
• Leadership and mentorship experience preferred.
• Engineering degree in Mechanical, Electrical or Chemical.
• Willingness to travel occasionally.

Responsibilities

• Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical/biopharmaceutical cGMP process equipment, utilities & facilities.
• Lead the development 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 – Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…), Downstream Bioprocess Equipment (Chromatography, TFF, etc..), Process equipment.
• 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 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.
• Lead/Mentor a team of validation engineers/specialists.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Skills

Validation leadership

Project management

cGMP knowledge

Process validation

Team mentoring

Cross-functional coordination

Regulatory compliance

Education

Engineering degree

Tools

PCS/SCADA systems

DCS/PLC control systems

IQ/OQ/PQ tools

Job description

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation 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 involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. This role requires to work on client sites in Augusta, GA, US.

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 – Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…), Downstream Bioprocess Equipment (Chromatography, TFF, etc..), Process equipment
• 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

• 5 + 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 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 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.