Cqv, Project Leader-ss

**Job Description**:
Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. Interfaces directly with IPS clients in the delivery of projects including routine communications, leading project meetings, tracking and reporting project metrics (financial and deliverables), self-directing and directing of assigned project team, maintains positive client relationship, etc. May also manage and perform standalone commissioning services for non-FDA regulated clients.

**KEY ACTIVITIES AND RESPONSIBILITIES**
- Assist an assigned Project Manager or is directly responsible for the successful delivery of compliance projects to IPS’ clients. Leads independent (sole individual), small, or mid-sized projects on behalf of IPS.
- IPS point of contact to client for day-to-day project delivery. Runs meetings, communicates status and project issues, frequently “checks-in” with client representative(s), and facilitates general project coordination activities.
- Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project managers or management of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
- Support, train, and provide guidance to validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
- Write and manage 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
- Perform and manage 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 and witnessing of vendor start-up and testing.
- Execution of C/Q/V protocols.
- Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
- Perform and manage staff in compiling data packages and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
- Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
- Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
- Audit project deliverables to assure compliance with established standards. Review work of assigned project team.
- Assist in proposal development including scope definition, attend bid meetings, development of hours and cost budgets, proposal presentations, etc.
- Act as an IPS representative for developing new opportunities and continue to support repeat business.
- Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
- Must be self sufficient and effectively work with limited to no supervision.
- Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services.
- Other duties as assigned.

Qualifications & Requirements:
**REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE**
- Bachelor’s degree in Engineering, or a related discipline or an equivalent technical degree,
- A minimum of 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, Process, Computer System, Methods and other validation activities and processes.
- Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.).
- Experience with Risk-Based Approach to Commissioning and Qualification, beneficial.

**CONTEXT AND ENVIRONMENT AND SAFETY**
- This position will have up to 100% travel to site, or as required by the assigned project.
- Position may be assigned to client site for an extended period of time.
- Overnight travel or staying in the city of Client’s location is possible depending on assignment.
- Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan.
- Position will visit Client sites and will be required to adhere to stated safety rules.
- Position may visit active construction sites and will be required