Write 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 field/site activities including, but not limited to, the following:
– Attend and witness FATs and SATs as a representative of 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.).
Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
Assists in deviation investigation and resolution for 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.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech and medical device industries.
Be self-sufficient and effectively work with limited supervision.
Read, understand and utilize the Best Practices and SOPs for delivery of compliance services.
Perform work to meet budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to project leaders, project managers or management of project status and issues.
Review the work of others and completed test scripts as an representative.
Develop client relationships and act as liaison on project/client sites.
Maintain professional conduct and deliver services in a professional and acceptable fashion.
Make recommendations to for possible project and procedural improvements.
Support and provide guidance for Level I & Tech staff and co-ops in the delivery of C/Q/V services.
Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
Special projects as assigned.
Qualifications & Requirements
Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case by case basis.
6 or more years of industry 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.
General exposure and experience in a GMP/Validation discipline 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.
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes, beneficial.
Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
Personal skills and traits include:
– Sense of urgency
– Team player
– Able to multi-task
– Effective time management
– Able to effectively prioritize
– Good interpersonal skills
– Attention to detail
– Excellent customer service skills