CQV Project Leader

				Overview:

IPS, a Berkshire Hathaway company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. IPS, inclusive of its Enterprise entities, has over 3,500 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.

Specialties

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.

All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

The salary offered for this role is between $117,900-$157,200, but actual salary offered is dependent on experience, skill set and education 

Responsibilities:

At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a CQV Project Leader to join our team at our office located in Emeryville, California.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. Interfaces directly with IPS clients in the delivery of projects. May also manage and perform standalone commissioning services for non-FDA-regulated clients.

Additional Responsibilities

* Assists an assigned Project Manager or is solely responsible for the successful delivery of compliance projects to IPS' clients. 
* Provides consistent, complete, and timely feedback and reports to IPS project managers or management on project status and issues. 
* Develops project schedules, deliverable tracking reports, scope adjustment notices, etc.
* Supports, trains, and guides validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
* Writes and manages others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
* C/Q/V Master Plans
* Commissioning Forms
* C/Q/V Protocols and Summary Reports
* Standard Operating Procedures
* Impact Assessments
* Specifications (URS/FRS/DDS)
* FATS/SATs

* Manages others during field/site activities, including, but not limited to, the following:
* Attend and witness FATs and SATs as a representative of IPS clients
* Execution of commissioning forms, witnessing of vendor start-up, and testing
* Execution of C/Q/V protocols
* Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
* Assists in deviation investigation and resolution of problems and issues encountered during field execution activities.
* Coordinates with the Project Delivery department or CM for start-up and vendor testing. 
* Assists in proposal development, including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.

* C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.

Qualifications:

* 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.
* 5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA.
* 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.
* General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical.
* Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
* Experience with a Risk-Based Approach to Commissioning and Qualification is beneficial.
* Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
* Demonstrated knowledge of Project Management Principles.
			

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