Job Details

Job Description

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 out of our office located in ____________.

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.

Position Responsibilities

1. Assist an assigned Project Manager or be solely responsible for the successful delivery of compliance projects to IPS' clients.
2. Provide consistent, complete, and timely feedback and reports to IPS project managers or management regarding project status and issues.
3. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
4. Support, train, and guide validation specialists/engineers in delivering C/Q/V services for assigned projects.
5. Write and manage others in the preparation of C/Q/V documents following established standards and templates, including but not limited to:
   • 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
6. Manage others during field/site activities including:
   • Attend and witness FATs and SATs as a representative of IPS clients
   • Execution of commissioning forms, witnessing vendor start-up and testing
   • Execution of C/Q/V protocols
   • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
   • Assist in deviation investigation and resolution of problems encountered during field activities.
   • Coordinate with the Project Delivery department or CM for start-up and vendor testing.
   • Assist in proposal development including scope definition, attending bid meetings, developing hours and budgets, proposal presentations, etc.
7. Perform C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.

Join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and elevates your career!

Qualifications & Requirements

• 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 executing 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 is beneficial.
• General exposure and experience in a GMP/Validation discipline with knowledge of pharmaceutical regulations.
• Understanding of Design/Build/Commission/Validation processes and their relation to regulatory requirements within the EU and U.S. FDA.
• Experience with a Risk-Based Approach to Commissioning and Qualification is beneficial.
• Proficiency with Microsoft Office applications.
• Demonstrated knowledge of Project Management Principles.

About Us

IPS, a Berkshire Hathaway company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. We provide consultancy services, architecture, engineering, project controls, construction management, and compliance services across over 45 offices worldwide. Visit www.ipsdb.com for more information.

We are an equal opportunity employer and value diversity at our company. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity, or any other protected status.