VALIDATION ENGINEERING MANAGER
Competitive Base Salary + Benefits + Bonus + Relocation
A senior leadership opportunity is available with one of the largest pharmaceutical companies in the world. This is your chance to not only be part of, but steer direction and drive growth for a multi-billion dollar organization.
Aside from leading the validation team, responsibilities for this position include defining and executing validation strategies for Madison and Verona sites in accordance with the appropriate GMP requirements, maintaining Site Validation Master plan, and qualification/re-qualification of facilities, equipment, computer systems, utilities, cleaning, and process.
You will also be responsible for successful validation and qualification of sub-contractors assuring sub-contractors meet the pertinent product, regulatory and corporate compliance.
- 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.
- Bachelor's degree in an Engineering related field
- Minimum four years' experience of a similar role within a cGMP environment is required
- Must be able to apply a risk-based approach to operation 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
- Ability to liaise with customer and intercept their requirements.
- Demonstrated ability to supervise and develop staff and work effectively will all levels of organization.