SR. VALIDATION SPECIALIST

Sr. Validation Specialist A Rochester, NY company is seeking a Senior Validation Specialist to join their growing team for an exciting direct-hire opportunity! Compensation for this role is contingent on experience and the organization offers an incredible benefits package, including an up to 10% 401K match and 7% bonus. Duties: Manages complex validation projects or multiple validation project activities under limited supervision, and performs assigned validation tasks such as validation product annual reviews and validated utilities re-certifications.Develops and executes equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities supporting these operations.Ensures appropriate validation activities are included in site or team project plans: including tasks, Client requirements, and duration.Performs proper and timely sampling of in-process/intermediate products and surface swabbing for testing as outlined by validation/qualification protocols.Analyzes data, utilizing appropriate statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.Gathers photocopies and compiles relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw materials certificates of vestigates and assists in resolving deviations/ exceptions from the predefined acceptance criteria.Draws conclusions from data, observations, deviation/exception and investigation as to whether a process is considered valid.Writes validation protocols (commissioning/ qualification, PQ, and Controls) for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.Writes summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/ qualification procedures and policies.Maintains protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.Ensures protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are maintained according to procedure.Keeps abreast of industry current practices, and modifies SOPs and validation practices to align with industry.Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. Requirements:Bachelor''s Degree in Science or Engineering Discipline preferred (Associates degree considered with relevant experience)5 years of experience in a validation or regulated GMP quality function preferred.Understanding of FDA requirements for depth knowledge of manufacturing equipment, utilities and processes.Ability to manage multiple projects in different phases of project completion, at varying times.

Created: 2021-11-29