Main responsibilities FATs: Attendance & support of execution at equipment FATsWalk down of mechanically complete systems including:Verification of installation in compliance with design and Client requirements.Identific…
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Full-time
bachelor degree
Posted 4h ago
~40 hrs/week
Responsibilities
The CQV Engineer is responsible for executing Design, Installation, and Operational Qualifications, including attending FATs and performing system walk-downs. They ensure all installations comply with design requirements and manage the closeout of punchlist items and change controls.
Requirements
Requires a minimum of a Bachelor's degree in Engineering or Science, preferably in Chemical, Mechanical, or Pharmaceutical Engineering. Candidates must have at least 3 years of experience in commissioning and qualification within the biopharma or pharmaceutical industry.
Full job description
Main responsibilities
FATs: Attendance & support of execution at equipment FATs
Walk down of mechanically complete systems including:
Verification of installation in compliance with design and Client requirements.
Identification of any technical issues as well as ergonomic and operational defects in the installation.
Clear communication of defects and punchlist items to the General Contractor and subcontractor and the later verification and approval of rectification of defects.
Communication with Client Subject Matter experts on the redline drawing, and technical issues arising from the walkdown.
Verification of the as-build design documents.
Marking updates to the drawing during walkdown.
Raising and closeout of Change control documentation to deal with any agreed changes to the design, in conjunction with the Client Subject Matter experts.
Witnessing of critical construction testing where relevant.
Review of turnover binders from the various relevant contractors, including:
Review of all construction test packs and verification of all construction quality documents including pressure test, weld inspection, material certification, passivation, loop checks etc.
Verification of all operation and maintenance turnover, including manuals, spare parts lists, training documents etc.
Execution of Design Qualification including:
Verification of the Client design in the relevant vendor design and turnover documents.
Raising of issues as they arise to the Client Subject Matter experts.
Raising of any change controls and deviations and discussing same with subject matter experts and Client reviewers.
Execution of Installation Verification including:
Verification of documentation for critical elements of the system including Execution of Installation Verification including Drawings, Manuals, Preventive Maintenance, Spare / Change Parts and Lubricants.
Verification (for critical components) of tagging, size/ range, material, installation and design compliance of all components including Instruments, Equipment, Piping, Valves/traps and other components.
Verification of spare/ change parts and preventative maintenance set-up.
Verification of drawings and other design as-builds.
Verification of installation/ construction testing and certification including pressure testing, cleaning/ passivation, calibration, loop checks, weld and material inspection and any other relevant construction quality documents.
These activities, especially for direct impact systems, must be leveragable.
Raising of issues as they arise to the Client Subject Matter experts.
Raising of any change controls and deviations and discussing same with subject matter experts and Client reviewers.
Execution of Operational Verification including:
Verification of the operation of the equipment including all automated and manual functions.
These activities, especially for direct impact systems, must be leveragable.
Raising of issues as they arise to the Client Subject Matter experts.
Raising of any change controls and deviations and discussing same with subject matter experts and Client reviewers.
Compliance with schedule including
Completion of tasks in a timely fashion on or before scheduled date.
Reporting progress for their systems, with
Accurate status and % completion being reported on all tasks.
Schedule risks clearly identified as they arise.
Identification and early resolution of any and all schedule risks including:
Verifying all test pre-requisites are in place including personnel, materials, utilities, equipment and instruments.
Verifying that all vendor and trade support is well planned and managed.
Verifying document availability and timely signoff of all documents.
Technical stewardship including:
Troubleshooting and resolving all issues.
Discussing and resolving with manager and subject matter experts all deviations, changes, design issues and test failures.
Safety Compliance including:
Preparation/ review of effective risk assessments and method statements.
Ensuring safe handover of systems with all LOTO, communication and training to make a safe and effective handover.
Making sure all tests are well planned and executed safely.
Understanding and following all Client procedures and policies.
Reporting and investigation into any safety incidents with Management and Client Safety group.
Key Performance Indicators
Strong knowledge and experience of Commissioning and Qualification.
Management: Compliance with schedule at a system and area level with the planned resource levels.
Feedback from customer (i.e. Quality, HSE, operations)
Safety: No lost time accident
Quality: well executed testing with minimum rework and re-execution.
Quality: all deviations resolved to Client satisfaction and handover completed for all systems.
Ideal Background
Education (minimum/desirable): Minimum BS or equivalent in Engineering or Science - preferably in Chemical, Mechanical or Pharmaceutical Engineering.
Experience in Commissioning and Qualification.
Languages: English - fluent in speaking and writing.
Experience: Minimum 3 yrs.
Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
41,286
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN
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