Validation Engineer

Work Location: Miamisburg, Ohio
Shift: No
Department: LS-SC-PEMM Engineering & Maintenance
Recruiter: Renay Middleton

Hiring Manager: John Shay

This information is for internals only. Please do not share outside of the organization.

Your Role:

In this role you will develop and execute validation protocols to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role is crucial for maintaining the quality and integrity of manufacturing processes and products.

Key Responsibilities:

• Develop and execute all validation activities for the facility, including planning, scheduling, execution, and project communication.
• Act as a key member of multi-department teams as the Validation representative, facilitating the introduction of new products/processes and troubleshooting existing ones.
• Proactively identify process operating problems and opportunities for improvement, developing innovative and cost-effective solutions.
• Create and execute validation protocols for equipment, analytical instrumentation, cleaning processes, and facilities, including FAT, SAT, IQ, and PQ documents.
• Maintain validation records and report metrics to site leadership, ensuring compliance with regulatory guidelines (FDA, EU, ISO, ISPE, 21 CFR Part 11).
• Collaborate with production operators, engineers, quality assurance staff, and contractors to coordinate validation schedules and execution efforts.

Physical Attributes:

• Wear Personal Protective Equipment for the duration of the shift.
• Lift up to 50 pounds.

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Chemical Engineering, Electrical Engineering, or other Engineering discipline.
• 3+ years of quality or validation experience in a cGMP pharmaceutical setting.

Preferred Qualifications:

• Experience with FDA and European regulatory guidelines.
• Strong leadership and communication skills.
• Experience with CAD software.
• Experience with Microsoft Project scheduling software.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.