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Merck · 18 hours ago

Associate Specialist, Commissioning and Qualification Engineer

Omaha, NE

Full-time

Onsite

New Grad, Entry Level

$72K/yr - $113K/yr

Merck is a leading global healthcare company, and they are seeking an Associate Specialist in Commissioning and Qualification Engineering at their Elkhorn facility. This role involves developing and executing commissioning and qualification protocols, ensuring compliance with regulatory guidelines, and collaborating with various departments to maintain validated systems and optimize processes.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

CommissioningQualificationGMP ComplianceTechnical Report WritingAseptic ProcessingData AnalysisProcess ImprovementsAccountabilityCommunicationProblem-SolvingAdaptabilityCross-Functional Teamwork

Required

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

Preferred

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