Validation Engineering Manager

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You will be responsible for defining and executing the validation strategy for the St. Louis CDMO operations at the Cherokee site in accordance with the appropriate GMP requirements for an API Contract Manufacturing Organization. You will lead the Validation team to ensure the execution of validation activities. Validation activities include qualification and re‑qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and process validation.

Provides subject matter expertise on validation activities including but not limited to, qualification and re‑qualification of facilities, equipment, computer systems, utilities, cleaning (facility and equipment), and process validation. Active participation with site projects and multi‑disciplinary teams with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance to ensure successful implementation and coordination of validation activities.

Direct interaction with customers to understand specific validation requirements, ensuring customer needs are met specifically as an API Contract Manufacturing organization. Responsible for the successful validation and qualification of sub‑contractors assuring subcontractors meet the pertinent product, regulatory and corporate quality requirements. Provide leadership and supervise activities and work assignments for validation activities at the site such as:

• Maintain Site Validation Master plan.
• Generate the Validation schedule, drive execution of workload and monitor performance to plan and track status of validation activities and documentation.
• Approve validation protocols prior to execution of work, ensuring content is accurate and delivered in a timely manner to meet schedule requirements.
• Plan and adhere to qualification and re‑qualification schedules. Establish and maintain system lifecycle documentation (e.g. Validation Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports.
• Evaluate data from executed validation protocols and ensure summary reports are generated and approved, ensuring quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables.
• Generate or approve Quality Risk Assessment documents in relation to executed validation activities.
• Assess and close deviations related to closure of validation activities and raise CAPAs as required.
• Actively participate in relevant change control activities and risk evaluation systems as they pertain to validation.

Location
:
Onsite St. Louis, MO – Cherokee Site CDMO

• Bachelor’s degree in an Engineering or Life Sciences discipline and/or equivalent years of practical experience
• Minimum five years’ experience in a similar role within a cGMP environment is essential, complemented with basic project management knowledge.
• 5 years of leadership (team lead, supervisor, manager) with a proven track record of motivating and managing a team of graduate level staff.
• Must be able to apply a risk‑based approach to operations and interpretation of resulting data.

• Experience in interaction with regulatory bodies and development of audit responses preferred.
• Knowledge of API products and CMO is desirable but not essential.
• Ability to liaise with customer and intercept their requirements.
• Innovative, decisive, results‑oriented leader with…