Operations Engineer

The Operations Engineer will work in a dynamic organization in the Operations team for North America. This role has the responsibility for supporting the on-time execution and delivery of sterile drug products. This role will report to the Director of Operations.

The Operations Engineer is the primary Operations contact to ensure reliability and quality compliance for manufactured products. This drives reliability improvements and takes a lead role investigating or reviewing deviations / out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce / prevent recurrence.

Work Schedule: 8am - 4:30pm Monday - Friday

• Maintain and manage to closure a list of reliability related improvement efforts for operations and engineering.
• Manages projects or initiatives specifically related to reliability improvements.
• Author and review Change Control / Quality Documents involving product or process changes.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Review validations (equipment, cleaning and/or process) for assigned area.
• Prepares and participates in regulatory agency (i.e. FDA, HC, TGA, etc.) audits as well as internal audits.
• QA contact for risk management activities, including FMEA's (Failure Modes and Effects Analysis).
• Investigate customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented in the sites EQMS (Electronic Quality Management System).
• Assemble, analyze and report batch data to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Develop, review and/or revise SOP (Standard Operating Procedures), BR's (Batch Records), OJT/OJQs, FMEA's with appropriate change management.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to quickly investigate and close deviation records ahead of product release.
• Ability to communicate with and positively influence broad and diverse cross-functional teams within and outside the organization.

• Bachelor's degree in Life Sciences or Engineering required.
• 2 or more years of relevant experience required. Pharmaceutical experience preferred.
• Significant experience investigating deviations and other variances, using Quality Engineering Tools and Techniques (i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot, Kepner-Tregoe, Comparative Analysis).
• Must be thoroughly familiar with applicable US and international regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment is strongly preferred.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must have experience with statistical tools Certification in Lean or Six Sigma preferred.
• Strong project management and organizational skills, including ability to work independently and as a team member
• Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Standard office environment, coupled with up to approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments
• Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.