Role Summary The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks, with responsibilities that may also include executing validation activities. Under the direction of the Validation Section Manager, this role participates in implementing the Validation quality program at the plant, with minimal supervision. Responsibilities may include reviewing commissioning and validation documentation, leading or reviewing investigations and implementing preventive and corrective actions, reviewing and authoring plant standard operating procedures, reviewing and approving critical planned maintenance routines, setting up laboratory samples for qualification, participating in the establishment of plant quality systems, and supporting regulatory and third-party audits. Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements. Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility. Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended. Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy. Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation. May supervise contract validation resources in the timely completion of activities in his/her area of responsibility. Qualifications Bachelor's degree, preferably in Biology, Chemistry or Engineering Prefer 2+ years of overall experience in Manufacturing, Quality or Engineering Good verbal and written communication skills. Good problem solving and analytical skills Good interpersonal relations / communications skills Good negotiation skills Prefer knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing. #J-18808-Ljbffr