Description

Responsibilities

• Direct, supervise, and develop the engineering team to ensure effective performance and professional growth – manage ongoing projects list, priorities, and performance expectations aligned with departmental and organizational objectives.
• Lead engineering support for troubleshooting, root cause analysis, and equipment performance meets established process parameters, throughput requirements, and quality standards.
• Oversee calibration, preventive maintenance, qualification, process validation and requalification of equipment, while ensuring all engineering activities comply with GMP regulations, internal quality standards, and applicable regulatory requirements.
• Review and maintain accurate and complete documentation in alignment with Quality Management System.
• Lead and assist VP of Engineering with planning, execution, and completion of capital projects related to equipment upgrades, facility enhancements, and capacity expansion.
• Maintain Cross Functional Collaboration with Operations, Quality and R&D to support production needs and resolve technical issues with all equipment and processes.
• Provide engineering expertise during internal audits, customer audits, and regulatory inspections.
• Promote a culture of continuous improvement, accountability, and technical rigor while maintaining focus to enhance process capability, equipment reliability, and operational efficiency.
• Ensure engineering activities are performed in a safe, efficient and productive manner which comply with all quality standards, company policies and procedures.
• Execute additional responsibilities, as assigned to support departmental and organizational objectives.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related field required).
• Minimum 10 years of engineering experience in a GMP regulated environment; sterilization experience strongly preferred.
• 3–5+ years of leadership or supervisory experience managing technical teams and demonstrated experience leading capital projects and facility or equipment upgrades.
• Experience with equipment qualification, process validation, revalidation and change control processes.
• Strong understanding of sterilization technologies and their operational requirements.
• In depth knowledge of cGMP regulations and quality system expectations within regulated manufacturing environments.
• Understanding of safety and environmental regulations related to sterilization operations.
• Demonstrated effective leadership skills with the ability to guide, mentor, and develop engineering teams to complete multiple tasks in a fast-paced highly regulated environment.
• Strong analytical and troubleshooting abilities with a practical, hands on approach.
• Excellent communication skills, including the ability to convey technical information clearly to cross functional teams.
• Strong organizational skills with attention to detail and documentation accuracy.
• Demonstrated ability to work independently as well as collaborate effectively with cross-functional teams to drive projects to completion.
• Outstanding verbal and written communication skills with experience in full Microsoft Office suite.
• Dependable, punctual and committed to maintain a positive attitude and strong work ethic

Key Skills

Education

Bachelor's degree