CQV Engineer

Glendale, CA, US • Posted 60+ days ago • Updated 1 hour ago

Full Time

On-site

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Job Details

Skills

Pharmaceutics
LOS
Mapping
Adobe AIR
Project Lifecycle Management
FMEA
Turnover
Safety Management
Quality Management
Supervision
Testing
Bill Of Materials
Performance Management
Preventive Maintenance
Project Management
Drawing
Acceptance Testing
Reporting
Training
Risk Assessment
Management
Change Control
Quality Audit
Auditing
Regulatory Compliance
Pharmaceutical Industry
Technical Writing
Documentation
Communication
Positive Attitude
Multitasking

Summary

Job Description:

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.

Responsibilities:
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.
ssist in site supervision of construction personnel.

Manage Installation and Operational Commissioning:

uthor and approve.
Execution.
Function Testing.
BOM Updates.
PM Generation.
sset Lifecycle.
Drawing Updates.
Support site acceptance testing to review system documents and functions during SAT.
Summary Report.

Manage Installation, Operational, and Performance Qualification:

uthor and approve.
Develop and execute qualification protocols.
ssist with any deviation resolution and handling execution.

Summary Report Training and Documentation:

Train personnel on the operation of the Fractionation process, and related procedures.
Create comprehensive documentation of all validation activities.

Risk Assessment and Mitigation:

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.

Quality Audits:

Conduct internal and external audits to ensure compliance with quality standards and regulations.

Requirements:

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: c4d08d98748b6375cb9a6d7b960c1022
Posted 30+ days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

CQV Engineer

Dice Job Match Score™

Job Details

Skills

Summary

Similar Jobs