Senior Plant Engineer
About The Position
This mid-career role, the Senior Plant Engineer, requires a highly skilled and experienced individual with a strong background in cGMP (current Good Manufacturing Practice) environments. This position 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.
Requirements
- Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or another similar field).
- 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.
- Strong data analysis and critical thinking skills to drive continuous improvement initiatives.
- Excellent troubleshooting and problem-solving skills.
- Proven ability to manage multiple projects and priorities.
- Strong communication and interpersonal skills.
- Experience with Quality Events, change controls, CAPA, investigations, deviation management, and audit support.
- Proficiency in creating and updating technical documentation and design specifications.
- Familiarity with automation and control systems (Rockwell Automation preferred).
- Ability to lead cross-functional teams.
- Basic familiarity in CAD software and other engineering tools.
Nice To Haves
- Experience with Blue Mountain, Maintenance Management Software (preferred).
Responsibilities
- Utilize knowledge of GMP regulations and pharmaceutical/biopharmaceutical manufacturing processes to support Abeona processes.
- Execute equipment commissioning/decommissioning and maintaining equipment calibration and preventive maintenance with reasonable independence.
- Creation and maintenance of documentation to support equipment procurement (i.e. user requirement specification) and commissioning protocols.
- Troubleshoot equipment and control system failures to minimize downtime and ensure consistent production.
- Develop and support spare parts and preventative maintenance programs.
- In collaboration with engineers and technicians, establish calibration ranges and critical process parameters.
- Analyze and enhance manufacturing processes to boost efficiency, reduce costs, improve product quality, and minimize variability.
- Manage engineering projects from conception to completion, including budgeting, equipment procurement, scheduling, and execution.
- Manage vendors and contractor communications, supervise when on site, partner with them for technical reports and other services.
- Provide oversight of engineering solutions to enhance plant performance and compliance.
- Support shutdown activities and start-up operations.
- Strict adherence to safety protocols.
- Create and update technical documentation including URS, FDS, Process Flow Diagrams, P&IDs, and isometric drawings.
- Maintain detailed records of execution.
- Collaborate with production, quality assurance, quality control, R&D, and Facility teams.
- Provide Technical support for troubleshooting and process optimization across departments.
- Mentor and train junior engineers.
- Daily communication with stakeholders at all levels.
Benefits
- Medical insurance coverage (multiple options to meet our employees' and their families' needs)
- Dental and vision coverage
- 401k match plan
- Lifestyle spending account
- PTO: 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
