Associate Specialist, Commissioning and Qualification Engineer

Merck•Omaha, NE

7d•Hybrid

About The Position

The Associate Specialist, Engineering C&Q position will fill a new role at the Elkhorn facility in support of the Commissioning and Qualification team. This position is responsible for developing and executing C&Q protocols across the site. The associate specialist will be responsible for communicating with stakeholders for testing requirements and scheduling. They will work closely with multiple departments on site to ensure equipment and utility systems maintain their validated state and new systems meet GMP requirements. Additionally, the role may take on additional responsibilities to develop skills and meet needs of the Engineering and Maintenance department. This can include troubleshooting equipment, implementing process improvements, investigating site deviations, and updating calibration records.

Requirements

Bachelor’s in Engineering required (Mechanical, Chemical, Electrical, Biomedical, Biochemistry or related discipline)
Understanding of aseptic processing and equipment cleanability
Strong analytical and problem-solving skills
Ability to write technical reports with key data and conclusions clearly presented
Ability to communicate and present information to groups with varied levels of technical background
Ability to work independently and in cross-functional teams
Use various hand-held measuring devices and manipulate components with dexterity
Sit, stand and walk for up to 8 hours or more per day
Lift and carry up to 25 lbs. on a limited basis
Climb stairs and ladders to access equipment components
Work at a computer for up to 8 hours per day
Tolerate working in unconditioned spaces ( ≥30°C) on a limited basis

Nice To Haves

Technical understanding of equipment and utility systems such as HVAC, purified water, clean steam, fermentors, bioreactors, autoclaves, and temperature control units including coolers, freezers, and incubators
Hands-on experience in commissioning, qualification or validation within the pharmaceutical, biotech, or related manufacturing industry
Awareness of Good Manufacturing Practices (GMP) in regard to documentation
Aseptic processing experience
Comfortable managing multiple priorities in a fast-paced environment

Responsibilities

Develop and execute commissioning, qualification, and validation protocols for equipment utilities and automated systems.
Perform system start-up, troubleshooting and performance verification to ensure readiness for operation.
Prepare and maintain C&Q documentation including protocols, reports, traceability matrices and risk assessments.
Ensure compliance with USDA, 9CFR and other regulatory guidelines.
Support the development and maintenance of validation master plans and user requirement specifications (URS).
Collaborate with Quality Assurance to ensure documentation meets internal and external audit requirements.
Work closely with Engineering, Maintenance, Manufacturing, Automation and Quality teams to ensure seamless project execution.
Identify opportunities to optimize C&Q processes, reduce cycle times and enhance equipment reliability.
Support change control activities and evaluate impact of modifications on validated systems.
Contribute to the development of standard operating procedures (SOPs) for best practices.