Validation Engineering Manager

Merck KGaA•Saint Louis, MO

63d•Onsite

About The Position

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. 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:

Requirements

Bachelor's degree in an Engineering or Life Sciences discipline and/or equivalent years of practical experience
Minimum five years' experience of a similar role within a cGMP environment is essential, complimented 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 operation and interpretation of resulting data.

Nice To Haves

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 strong coaching and problem-solving skills.
Ability to multitask and prioritize independently in a fast-paced environment.
Demonstrated ability to supervise and develop staff and work effectively will all levels of organization.
Excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions.

Responsibilities

Maintain Site Validation Master plan.
Generates the Validation schedule, drives execution of workload and monitors performance to plan and tracks status of validation activities and documentation.
Approves validation protocols prior to execution of work, ensuring content is accurate and in a timely manner to meet schedule requirements.
Plan and adhere to qualification and requalification schedules. Establish and maintain system lifecycle documentation (e.g. Validation Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports.
Evaluates data from executed validation protocols and ensures summary reports are generated and approved, Ensuring quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables.
Generates or approves Quality Risk Assessment documents in relation to executed validation activities.
Assesses and closes deviations related to closure of validation activities and raises CAPA's as required.
Actively participates in relevant change control activities and risk evaluation systems as they pertain to validation.