• 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
• 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
• 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
• Work at a computer for up to 8 hours per day
• Travel: Less than 10% travel required

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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
• Tolerate working in unconditioned spaces ( ≥30°C) on a limited basis

Limited off shift work may be required to meet project, operations, and qualification needs

• Bachelor’s in Engineering required (Mechanical, Chemical, Electrical, Biomedical, Biochemistry or related discipline)

Accountability, Accountability, Adaptability, Biochemistry, Biopharmaceutical Operations, CAD Proficiency, Change Control Processes, Communication, Construction, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, External Audit, Gauging, GMP Compliance, Good Manufacturing Practices (GMP), High Technology Industry, Immunochemistry, Mechatronics, Process Improvements, Process Optimization, Professional Engineering, Project Management {+ 4 more}

Climb stairs and ladders to access equipment components $71,900.00 - $113,200.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.Company.com/us/en/compensation-and-benefits

No relocation