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.
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.
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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