Pharmaceutical - VALIDATION ENGINEER - Raleigh, United States - MMR Consulting

Description

Job Description

Pharmaceutical - VALIDATION 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 the US and Canada. 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).

MMR's services range throughout all stages of pharmaceutical projects. A typical engineering project may include support from initial concept development, up to technical support after systems have initiated operations, in addition to acting as an 'owner's representative' throughout the project. Our vision is to be a customer focused, engineering and consulting firm, and to make complex projects seem very seamless for our clients. A breakdown of a typical engineering project's services may include initial feasibility assessment, budget, scope, schedule development and project planning, various stages of engineering and specifications development, tendering and management of suppliers and contractors, supervising installations, authoring and executing commissioning and validation protocols, performing start-up activities such as training, technical support, SOPs, spare parts implementation.

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 may require working out of client's facilities, which are typically in the Greater Chicago Area (within one hour driving distance of Chicago).

We are hiring at different levels (Senior / Intermediate / Junior) based on years of experience. Please refer to Position Level section.

Responsibilities

• Provide technical guidance into the Process Validation (PV) and / or Cleaning Validation (CV) aspects of Manufacturing Science and Technical Operations (MSAT) in the pharmaceutical / biopharmaceutical cGMP manufacturing or R&D operations
• Lead the development of validation strategies or deliverables such as protocols, reports, deviation resolution process and training during the project validation lifecycle
• Able to perform field execution of validation 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 such as DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and regulatory specifications are met.
• Serve as Validation SME, coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates for execution of validation activities.
• 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

• 1 – 12+ years of experience in Process Validation and / or Cleaning Validation within a MSAT group within the pharmaceutical/biotech cGMP manufacturing operations.
• Possess knowledge of relevant regulatory requirements and industry best practices on assessing / implementing all or any of the following –
• PV – Process variation sources, presence detection and degree, impact and controls, DoE, PPQ, gap analysis, process design, process qualifications & continued process verification
• CV - Cleaning & Sanitization, Holding times (DEHT / CEHT), Cycle times, FIP/CIP/SIP, CCP, MAR, wetted/non-wetted product contact areas, sampling methods and analysis
• Experience with biotech manufacturing processes would be a definite asset.
• 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.
• 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.
• Science / Engineering degree
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Position Levels

• Senior > 12 Years
• Intermediate 5 – 12 Years
• Junior 1 – 4 Years

Send your resume to:

MMR Consulting is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, etc. To learn more about MMR, please visit

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.