What are the responsibilities and job description for the CQV Engineer position at Katalyst CRO?
Job Description
Full Scope Of Project
- A large pharmaceutical company in Los Angeles is in immediate need of a CQV Engineer for a 12-month project, this is an onsite position and is 40 hours/week.
- The client needs someone with Facilities CQV experience including EMPO, Vessel IOV and IOPQ including mixing and temp mapping. They have personnel assigned to Utilities (WFI, Alcohol, N2, Compressed Air, etc.), CIP, Filter Press, Centrifuge, CIP skids, and Cleaning Validation; this experience is preferred in case they need additional support. The project also requires daily job walks of the construction site daily in full PPE.
Full Scope Of Project
- Generation and Modification of project lifecycle documentation for LA Plant Site.
- User Requirement Specifications.
- Functional Specifications.
- Design Specifications.
- SOPs.
- Management of Change (MOC).
- FMEA.
- HAZOPs.
- Risk Assessments.
- Gap Assessments.
- Project Closeout Documentation.
- Turnover Package Generation.
- Project Change Requests.
- Construction Activities.
- Generate and Manage Safety Management Plans and Documentation.
- Disruptive Construction Activity Requests.
- Job Hazard Analysis.
- Lockout Tag Out Plan.
- Hot Work Permitting.
- Permit to Work.
- Detour Plans.
- Construction Signage.
- Plant-wide Communications.
- Generate and Manage Quality Management Plans and Documentation.
- Construction Control Plan.
- Assist in site supervision of construction personnel.
- Author and approve.
- Execution.
- Function Testing.
- BOM Updates.
- PM Generation.
- Asset Lifecycle.
- Drawing Updates.
- Support site acceptance testing to review system documents and functions during SAT.
- Summary Report.
- Author and approve.
- Develop and execute qualification protocols.
- Assist with any deviation resolution and handling execution.
- Train personnel on the operation of the Fractionation process, and related procedures.
- Create comprehensive documentation of all validation activities.
- Identify and assess potential risks to product quality and patient safety.
- Develop mitigation strategies and contingency plans.
- Change Control:
- Manage change control for any modifications or updates to the equipment or processes.
- Conduct internal and external audits to ensure compliance with quality standards and regulations.
- BS degree minimum.
- 2-10 years of Validation Engineering experience in pharmaceutical industry.
- Strong skill set in installation and IQOQ of equipment like centrifuges, filter presses, and processing tanks.
- Cleanroom qualification experience is a plus.
- Very strong technical writing/documentation skills.
- Very strong communication skills and ability to coordinate with cross-functional teams.
- Experience doing job walks with engineers for capital projects.
- Must have a positive attitude and ability to multi-task.
- Must be committed to supporting a long-term project that could go for 2 years.
- Must be available to support other shifts as requested by the client, this could happen on short notice.