SMPA operates a regenerative medicine manufacturing facility in Morrisville, NC to support both commercial and clinical needs. We are looking for a Sr Engineer to support the on-going manufacturing activities. Main roles include managing small projects, change controls, CAPA’s, equipment troubleshooting, and investigations related to processing equipment including isolators, biosafety cabinets, incubators, freezers, and refrigerators. This position will be onsite at the manufacturing facility with core hours of 8:00 AM to 5:00 PM Monday through Friday.  The position will also require after hours support on an on-call rotation.

Job Duties and Responsibilities

• Troubleshoots equipment systems and associated automation systems for production and utility equipment (with a focus on isolator technology and hydrogen peroxide decontamination processes).
• Identifies and leads equipment related capital projects.
• Directs and supports the design, specification, and installation of new or modified equipment.
• Develops and supports equipment commissioning and validation activities.
• In collaboration with the Quality Assurance department, ensures that all activities are executed in compliance with regulatory guidelines.
• Develops preventative maintenance and calibration requirements for new equipment and instruments.
• Maintains personal training and goal development/completion.
• Manages and provides direction to contractors.
• Ensures production equipment meets cGMP’s and are regulatory inspection ready. Support investigations and associated CAPAs as required.
• Contributes to risk analysis and mitigation plans to ensure product quality.
• Works closely with cross-functional teams (e.g., manufacturing and quality) to meet production and project milestones.
• Supports Environmental, Health, and Safety projects and initiatives.
• Utilizes project management tools such as schedules, action lists, and clear scope definition to ensure the timely implementation of equipment improvements and compliance task (e.g., change controls, investigations, and corrective and preventative actions).
• Regularly communicates with internal and external stakeholders including presentation of initiatives to senior management.
• Participates in regulatory audits as the engineering subject matter expert

Key Core Competencies

• Open, and collaborative working relationships with internal and external stakeholders.
• High attention to detail.
• Strong problem-solving ability to troubleshoot and communicate appropriately and effectively.
• Ability to work safely and conscientiously in manufacturing and laboratory environments.
• Ability to identify and address compliance, environmental, safety, and process deviations as required, with ability to escalate to appropriate personnel.

Education and Experience

• Minimum of 4 years of relevant pharmaceutical/biotechnology experience.
• Bachelor’s degree in chemical engineering, biochemistry, pharmaceutical sciences or equivalent
• Experience with sterile or aseptic processing equipment and GMP manufacturing is required.
• Experience supporting isolator technology and associated air handling equipment is preferred.
• Experience with contractor management is preferred.
• Ability to work on-site and periodic on-call availability is required.

• Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.
• Individuals will be required to work in a clean room environment.