CQV, Project Leader

Overview

Lead cGMP commissioning, qualification, and validation projects for pharma/biotech clients.

Key Responsibilities

• proposal development
• validation support
• deviation investigation
• system verification
• commissioning testing
• c/q/v execution

Tasks

-Assists in proposal development including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc. -Supports, trains, and guides validation specialists/engineers in the delivery of C/Q/V services for assigned projects. -Assists in deviation investigation and resolution of problems and issues encountered during field execution activities. -Walkdown and verification of system drawings (P&IDs, as-builts, etc.) -Execution of commissioning forms, witnessing of vendor start-up, and testing -Develops project schedules, deliverable tracking reports, scope adjustment notices, etc. -Provides consistent, complete, and timely feedback and reports to IPS project managers or management of project status and issues. -C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. -Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA. -Execution of C/Q/V protocols -Coordinates with the Project Delivery department or CM for start-up and vendor testing. -Attend and witness FATs and SATs as a representative of IPS clients -Writes and manages others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following: -Assists an assigned Project Manager or is solely responsible for the successful delivery of compliance projects to IPS’ clients. -Manages others during field/site activities including, but not limited to, the following:

Requirements

• bsc engineering
• c/q/v protocols
• 5+ years
• gmp validation
• microsoft office
• project management

What You Bring

-A Bachelor of Science in Engineering is required for an Engineer; a Bachelor of Science in a related field is required for a Validation Specialist. -C/Q/V Protocols and Summary Reports -5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA. -General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical. -Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.). -Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software. -Experience with Cleaning, Processes, Computer Systems, Methods, and other validation activities and processes is beneficial. -Demonstrated knowledge of Project Management Principles. -Specifications (URS/FRS/DDS)

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About Ips-Integrated Project Services

-Founded with the vision of delivering exceptional project solutions, the company is a trusted partner in the global construction and engineering sector. -From concept to completion, the company offers comprehensive services across various industries, including industrial, energy, infrastructure, and commercial sectors. -The company has a rich history of delivering large-scale, complex projects, with a focus on high-quality standards, safety, and sustainability. -Specializing in end-to-end project delivery, the company ensures that projects are managed efficiently, from initial planning through to construction and commissioning. -Notable for its ability to handle both small-scale and large-scale ventures, the company is recognized for its expertise in managing projects for major players in energy and industrial markets. -The company's deep technical expertise allows them to bring innovative solutions to life, working across sectors like nuclear, water resources, and heavy civil engineering. -With a solid track record in the design and build of cutting-edge facilities, the company stands out for its dedication to technical excellence and client satisfaction.

Sector Specialisms

Interview Process

-interviews are conducted in person or virtually, with video required.