Operations Engineer

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-390475

Yoh is hiring an Operations Engineer for our Pharmaceutical Manufacturing client in Indiana. This is a great opportunity to join a growing team and expand your skills

Essential Job Funtions:

• 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.

• 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.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities