| Position Overview |
| A highly skilled and experienced Senior Plant Engineer with a strong background in cGMP (current Good Manufacturing Practice) environments. This role is pivotal in the design, implementation, and maintenance of critical GMP plant systems within a biopharmaceutical manufacturing setting. Key responsibilities include ensuring operational efficiency, reliability, and compliance; supporting calibration, preventative maintenance; both manufacturing and R&D initiatives; and completing commissioning and decommissioning activities. The role also involves evaluating and improving production and quality control processes while providing technical expertise and driving continuous improvement across various projects. |
| Essential Duties and Responsibilities |
- Strong knowledge of GMP regulations and pharmaceutical/biopharmaceutical manufacturing processes.
- Competent in executing equipment commissioning/decommissioning and maintaining calibration and preventive maintenance.
- Ability to troubleshoot equipment and control system failures to minimize downtime and ensure consistent production.
- Experience in developing and supporting spare parts and preventative maintenance programs.
- Skilled in establishing calibration ranges and critical process parameters.
- Demonstrated expertise in analyzing and enhancing manufacturing processes to boost efficiency, reduce costs, improve product quality, and minimize variability.
- Strong data analysis and critical thinking skills to drive continuous improvement initiatives.
- Proficient in managing engineering projects from conception to completion, including budgeting, equipment procurement, scheduling, and execution.
- Experience in managing vendors and contractors.
- Oversight of engineering solutions to enhance plant performance and compliance.
- Support for shutdown activities and start-up operations.
- Strict adherence to safety protocols.
- Experience with Quality Events, change controls, CAPA, investigations, and audit support.
- Specialist in creating and updating technical documentation including URS, FDS, Process Flow Diagrams, P&IDs, and isometric drawings.
- Maintaining detailed records of execution.
- Effective collaboration with production, quality assurance, quality control, R&D, and maintenance teams.
- Technical support for troubleshooting and process optimization across departments.
- Experience in mentoring and training junior engineers.
- Strong communication and interpersonal skills to engage with stakeholders at all levels.
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| Qualifications |
- Bachelor's degree in Engineering.
- 6 to 10 years of experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment.
- Proven experience with plant utilities, equipment commissioning/qualification, and process optimization.
- Strong knowledge of cGMPs and industry best practices.
- Excellent troubleshooting and problem-solving skills.
- Proven ability to manage multiple projects and priorities.
- Strong communication and interpersonal skills.
- Experience with change controls, CAPA, and deviation management.
- Proficiency in creating and updating technical documentation and design specifications.
- Experienced in Project Management (PMP) or similar.
- Familiarity with automation and control systems.
- Ability to lead cross-functional teams.
- Proficiency in CAD software and other engineering tools.
- Experience with Blue Mountain, Maintenance Management Software.
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| Physical Demands |
- This position may require occasional evening or weekend work to address urgent issues or meet project deadlines.
- The role involves working in both office and plant environments, with exposure to manufacturing equipment and processes
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