| Validation Engineer /CQV Engineer at Remote, Remote, USA |
| Email: [email protected] |
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Validation Engineer /CQV Engineer Location : Los Angeles, CA (100% onsite) Experience : 5+ years of pharmaceutical experience Responsibilities: Project Support: Attend project meetings at various frequencies (weekly, daily, monthly) Generate work orders, memos, interoffice correspondence, and meeting minutes Develop and maintain project lifecycle documentation for the LA Plant Site, including: User Requirement Specifications Functional Specifications Design Specifications Standard Operating Procedures (SOPs) Management of Change (MOC) documents Failure Mode and Effects Analysis (FMEA) Hazard Operability Studies (HAZOPs) Risk Assessments Gap Assessments Project Closeout Documentation Turnover Package Generation Project Change Requests (PCRs) Manage Project Change Control Records (PRs) through initiation, management, and closure Support the Architectural/Engineering (A/E) firm throughout the project design phases: Conceptual Design Basic Design Detailed Design Design Review Generate and manage safety documentation for construction activities, including: Safety Management Plans Disruptive Construction Activity Requests Job Hazard Analysis (JHA) Lockout/Tagout (LOTO) Plans Hot Work Permits Permits to Work Detour Plans Construction Signage Develop and maintain plant-wide communication plans Quality Management: Generate and manage quality management plans and documentation, including: Construction Control Plan Assist in site supervision of construction personnel Manage installation and operational commissioning activities: Author and approve commissioning plans Oversee execution of commissioning activities Conduct functional testing Update Bill of Materials (BOM) Generate Preventive Maintenance (PM) procedures Manage asset lifecycle data Update drawings Support site acceptance testing (SAT) by reviewing system documents and functionalities Validation Support: Participate in various validation activities, including: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Process Validation Cleaning Validation Facility Qualification Software Validation Compile validation reports summarizing activities, results, conclusions, and recommendations for ongoing monitoring and maintenance Qualifications: Bachelor's degree in Engineering or a related field (preferred) Minimum of 2 years of experience in project engineering or a related field Strong understanding of project management principles and methodologies Excellent written and verbal communication skills Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) Familiarity with project management software (e.g., Primavera P6, MS Project) is a plus Working knowledge of quality management principles (e.g., Good Manufacturing Practices (GMP)) is a plus Experience with validation activities in a pharmaceutical or related industry is a plus Additional Skills: Strong analytical and problem-solving skills Ability to work independently and as part of a team Excellent attention to detail and accuracy Ability to prioritize and manage multiple tasks simultaneously Ability to travel occasionally (may be required) Kind Regards, Syeda Hajra | Absolute IT | Senior Technical Recruiter 116 Village Blvd Suite 200 Princeton New Jersey 08540 Absolute IT Direct: (609) 934 3457 Office: 201-228-3009 EXT 140 [email protected] https://www.linkedin.com/in/syeda-hajra-a96813245/ www.absoluting.com -- Keywords: information technology microsoft California Louisiana Validation Engineer /CQV Engineer [email protected] |
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| 01:01 AM 18-Jul-24 |