MV05-022325 Commissioning & Qualification Technical Lead

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning & Qualification Technical Lead

Description:

The Commissioning & Qualification Technical Lead is responsible for planning, preparation, coordination and leading a CQ team from documentation preparation through Design, FAT, CM oversight, MC, integrated CQ execution and successful handover to the Client USER team.

• The scope of CQV activities relates to Process and Process Support Equipment. The CQ SME will lead and coordinate a CQV team that consists of CQV leads/specialists, engineers, operations personnel, engineering and external vendors, contractors, sub-contractors including the automation integrator and CSV service provider.
• Aside to delivering in line with the Client C+Q requirements, the CQ Lead will ensure that overall Budget, Baseline Schedule, Compliance, Quality and HSE objectives are achieved in line with Project expectations. The CQ Lead will form part of the Client leadership team attending core team meetings, providing guidance on CQ matters and representing PDP in terms or contractual obligations.

Qualifications:

• Bachelor's Degree in Engineering or Science.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.