The Validation Engineer III performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer III assist with internal project teams and external validation firms on validation/qualification initiatives and ensures project schedules are met. Complies with requirements of the Safety Program, including OSHA requirements. In carrying out duties, contributes and promotes a positive and equitable working environment emphasizing the
- Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ.
- Review commissioning, qualification, and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning, and qualification protocols).
- Assist with direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
- Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables.
- Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation.
- Validation representative on validation projects leading by example on projects.
- Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
- Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities
- Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated.
- Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping teammates and manager informed and providing guidance to other engineers as needed.
- Write protocols and technical study approaches.
- Review document changes for validation and deviation impact.
- Propose corrective actions to validation manager and appropriate departments to implement the required changes.
- Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
- Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
- Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Steam Sterilization,
- Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
- Possess strong knowledge of commissioning, qualification validation, practices, including applicable regulations.
- Excellent technical writing, verbal communication, and presentation skills.
- Proficiency in Microsoft Office including Word, Excel, Power Point, Project
- Bachelor's degree in Engineering or related scientific discipline required with a minimum of 6 years of pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, or Engineering.
- Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment.
- Professional and collaborative team player must have strong interpersonal skills.
- Honesty, integrity, respect, and courtesy with all colleagues.
- Ability to inspire others to strive for excellence.
- Self-motivated and able to meet goals with minimal supervision.
PHYSICAL REQUIREMENTS & MENTAL DEMANDS:
- Ability to lift 50 pounds
- Must be able to stand for long periods of time each day
- Travel and work at all site locations/facilities
- Ability to multitask with competing demands and at times shifting priorities.
- Able to don ISO cleanroom gowning and PPE, as required by site procedures.