Senior Manager, Process Validation

Location: Greenfield, IN
Work Arrangement: Hybrid, onsite 3 days per week
Relocation: Relocation assistance available
Department: Engineering

Job Summary

Reporting to the Director of Global Validation and Metrology Services, this position is responsible for contributing to the development and implementation of the global validation engineering strategy while ensuring the qualification and validation of equipment, facilities, utilities, automated systems, manufacturing processes, and cleaning processes in accordance with GMP requirements and applicable regulatory guidelines.

The position provides technical and strategic leadership across multiple manufacturing sites and helps improve manufacturing processes, validation practices, and technical solutions within a regulated environment.

Essential Duties and Responsibilities

• Provide technical leadership and direction to a globally dispersed Validation Engineering team, including validation strategy, planning, and execution.
• Provide strategic leadership supporting long-term and intermediate operational goals.
• Direct validation resources in support of technical and manufacturing programs across multiple sites.
• Participate in the harmonization and implementation of validation standards and procedures based on current regulations, industry standards, and best practices.
• Drive innovative and efficient validation approaches using science-based and risk-based methodologies.
• Oversee preparation, review, and approval of Site Validation Master Plans.
• Review and/or approve qualification and validation documentation, including specifications, protocols, and reports.
• Provide validation oversight for equipment, instrumentation, facilities, utilities, automated systems, manufacturing processes, and cleaning processes.
• Support and oversee FAT, SAT, IQ, OQ, and PQ activities.
• Oversee third-party-generated validation protocols and reports in conjunction with Quality.
• Promote shared learning and technical best practices across manufacturing sites.
• Lead and participate in validation meetings.
• Perform periodic system reviews to maintain validated status.
• Support electronic validation documentation systems and compliant archiving of validation records.
• Oversee implementation of site validation strategies to meet business and customer requirements.
• Collaborate across departments to ensure new processes meet technical, quality, and operational requirements.
• Support technical transfer programs and transition of new processes into Operations.
• Participate in customer meetings as a technical/validation representative.
• Assist with training and development of personnel on new processes and systems.
• Ensure appropriate procedures and systems are in place for introducing new equipment and processes.
• Lead and manage a high-performing team to achieve defined business objectives.
• Perform additional responsibilities as required.

Education

Bachelor's degree or higher in Computer Science, Engineering, or a related technical field.

Required Experience

• Minimum 10 years of Validation Engineering experience within a cGMP-regulated industry.
• Minimum 10 years of post-graduate experience in a high-volume manufacturing environment, preferably within the pharmaceutical or medical-device industries.
• Previous people-management experience.

Knowledge, Skills and Abilities

• In-depth/working knowledge of ISO 13485, EU GMP, and CFR Part 820.
• Strong understanding of validation principles within regulated manufacturing.
• Experience with equipment, facilities, utilities, automated systems, manufacturing-process and cleaning validation.
• Experience with FAT, SAT, IQ, OQ and PQ.
• Understanding of plastic-process manufacturing, computer-system validation, analytical methods, testing, and documentation systems is preferred.
• Previous customer-facing experience.
• Excellent written and verbal communication skills.
• Strong technical documentation skills.
• Demonstrated ability to lead, influence, develop, and train others.
• Ability to operate effectively in a fast-paced manufacturing environment.
• Strong organizational and prioritization skills.
• Detail-oriented and self-motivated.
• Ability to collaborate across functional teams in a matrixed organization.
• Ability to independently manage projects while working concurrently with multiple departments.
• Experience supporting continuous-improvement/Lean Sigma initiatives.
• Ability to comply with applicable safety and quality policies.

Travel

Approximately 5% travel, up to 13 business days per year.

Additional Information

This is a hybrid position requiring onsite work 3 days per week. Relocation assistance is available.

The employer is an established global manufacturer operating in a highly regulated industry.

Nearest major market: Indianapolis