19 days ago
The Critical Utilities Team is actively seeking a Site Mechanical Engineering SME to serve as the subject matter expert in Mechanical Engineering for ongoing projects in Pharmaceutical manufacturing systems and Critical Utilities (Clean & Black), Manufacturing. Join us in ensuring the efficient operation and reliability of our site's Mechanical systems.
- Compliance Assurance:
- Ensure modifications and additions to systems comply with Regulatory requirements, including Quality (cGDP/GMP's), EHS, CE Compliance, Global Engineering, and local regulations in Mechanical discipline.
- User Requirements Development:
- Develop user requirements for new equipment and modifications, collaborating with stakeholders from concept to installation.
- CMMS Data Management:
- Develop, review, and update CMMS data, calibration data sheets, spare parts requirements, PMs, PdMs, job plans, etc., to optimize reliability-based maintenance programs.
- Root-Cause Failure Analysis:
- Perform and facilitate root-cause failure analysis (Cause Mapping) on chronic/critical/high-impact failures.
- Preventative and Predictive Maintenance:
- Minimize unscheduled equipment downtime through effective preventative and predictive maintenance programs and rapid response to equipment failure.
- Vendor and Contractor Oversight:
- Review and accept reports from vendors and contractors, develop action plans, and raise CMs/PMs/Pdms to address issues.
- Compliance Support:
- Support all compliance efforts, including risk assessments, RCA investigations, CAPAs, and the review/approval of engineering change controls.
- Project Management:
- Raise Project Request Documents (PRDs) and manage projects for site improvements or the addition of new equipment.
- Continuous Improvement:
- Advocate for continuous improvement in processes and systems.
- Audit Support:
- Support site audits with the Engineering technical services SME team as required.
- Designee Responsibilities:
- Serve as a designee for the Critical Utilities, Clean utilities, or HVAC SME in appropriate circumstances.
- Team player with leadership capabilities in a collaborative environment.
- Ability to provide solutions aligned with business objectives and cost implications.
- Detailed knowledge and experience in operating and designing Mechanical systems.
- In-depth knowledge of regulatory requirements in the pharmaceutical/biopharmaceutical industry.
- Experience dealing with regulatory agencies.
- Proficiency in managing complex projects in or around operating facilities.
- Ability to work independently and remotely with minimal supervision.
- Proactive problem-solving using Technical, Project Management, and Business expertise.
Required Qualifications and Desired Experience:
- Level 7/8 qualification in Mechanical Engineering / Chemical / Process Engineering.
- Minimum 8 years of experience in pharmaceutical manufacturing facilities in a Projects design, maintenance engineering, or utilities engineering
The Next Step for you:
Should this position be of interest to you please forward your CV to Nuira Esmau at Next Generation Recruitment via the Apply button.
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