Senior CQV Engineer - Carlsbad, United States - MMR Consulting Inc

Description

Biopharmaceutical Senior CQV Engineer

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. MMRs 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. The work will require working out of clients facilities in Carlsbad, California.

Responsibilities

• Provide technical guidance into the commissioning, qualification 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
• 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, building & facilities (Water system, Steam, HVAC system, clean air, CIP etc.)
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, process, mechanical, architectural, facilities, and electrical.
• Review Factory Acceptance Testing (FATs) Protocols and leverage for commissioning, as required.
• Review of P&IDs and establishing system boundary.
• Generation of System Test Matrix.
• 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.
• Generation and execution for GMP systems in electronic system (Valgenesis).
• 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 clients safety rules including mandatory vaccination policies for COVID-19, where applicable
• Lead/Mentor a team of validation engineers/specialists.

Qualifications

• 8+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, knowledge of requirements for cGMP operations.
• 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, is 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: Autoclaves, Washers and Clean Utilities is required.
• Experience with preparation and execution 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 fast-paced environment.
• Strong multi-tasking skills

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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.