Operations Engineer

Job Overview:
We are seeking an Operations Engineer to support manufacturing activities within a regulated sterile drug product environment. This position focuses on ensuring reliable operations, maintaining quality and regulatory compliance, and supporting on-time product delivery. The role partners closely with cross-functional teams to investigate issues, drive continuous improvement, and support validated processes. The ideal candidate brings strong problem-solving skills and experience working in a cGMP-controlled setting.

Job Responsibilities:

• Lead and track reliability improvement initiatives across operations and engineering functions

• Manage projects aimed at improving process performance, uptime, and product quality

• Author, review, and implement change control documentation related to process or product updates

• Ensure compliance with applicable global regulatory requirements and quality standards

• Support validation activities including equipment, cleaning, and manufacturing processes

• Participate in internal audits and regulatory inspections, providing documentation and technical support

• Perform risk management activities, including development and maintenance of FMEA assessments

• Investigate deviations, out-of-specification results, and customer complaints using root cause analysis methods, ensuring timely closure within quality systems

• Analyze batch data to confirm compliance, identify trends, and recommend process improvements

• Develop and maintain controlled documents such as SOPs, batch records, and training materials

Qualifications:

• Bachelor’s degree in Engineering or Life Sciences required

• Minimum of 2 years of experience in a regulated manufacturing environment, pharmaceutical experience preferred

• Demonstrated experience conducting deviation investigations using structured problem-solving tools such as 5 Whys, Fishbone, or similar methodologies

• Working knowledge of cGMP requirements, particularly in sterile or aseptic operations strongly preferred

• Familiarity with regulatory expectations for validation, documentation, and quality systems

• Experience collaborating across departments to resolve issues and maintain compliance

• Proficiency with statistical analysis tools; Lean or Six Sigma training is a plus

• Strong organizational, project management, and communication skills

• Advanced proficiency with Microsoft Office applications and project tracking tools