Validation Engineer

Job Title: Validation Engineer Job Type: Full-time direct hire Job Location: Le Sueur, MN (Onsite) Salary: $80k-$85k/annum Work Authorisation: US Citizen/GC Job Description · Review, plan, schedule and organize validation projects for new and existing areas, including manufacturing equipment, processes, plant systems, storage facilities and equipment. · Develop and implement all necessary standard operating procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities. · Design IQ/OQ/PQ and validation campaigns, develop, prepare, and write the protocols for process validation, equipment validation, cleaning validation, IQ/OQ and performance qualification. · Coordinate validation and IQ/OQ/PQ activities with production, quality control laboratories and outside contractors providing leadership, training, and guidance. · Review and analyze moderately complex analytical and physical data generated from validation activities. Write validation final reports that present, summarize, and offer conclusions on the validity of the process based on the results of the analysis and obtain necessary approvals on a timely basis. · Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results, and assisting production in resolving any identified problems. · Recommends validation approaches / strategies, priorities, and resources required. Accountable for accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities, accountable for meeting critical deadlines for complex projects. · Provides validation support to Regulatory Affairs Department for product submissions and regulatory filings · Remain current on legislative, regulatory, and technical changes within the industry, and on training requirements within the facility. Continually develops expertise and acts as a technical expert for the various validation and production activities · Schedule and coordinate calibration events. Log and maintain calibration certificates and records both hard copies and operation of the Blue Mountain RAM program in the Le Sueur facility. · Assign equipment asset number to new equipment and manage calibration, verification, and maintenance records for the new equipment · Performs regular validation and performance qualification audits as necessary to ensure conformity to all regulatory requirements. Identifies areas of validation failure or deviations from established process and product standards, providing recommendation to solve identified problems · Participates in regulatory audits by government regulatory agencies and audits by customers · Conducts validation reviews as needed for the facility’s change control process, deviation process and batch records. · Create and validate batch record calculations sheets as required · Create and maintain drawings and diagrams for regulatory agencies and in plant use · Support the North American Project Manager and other management in equipment selection and facility modifications. This includes preparing or supporting URS, researching equipment options, obtaining equipment quotations, assisting in preparing capital equipment expense requests, and ensuring equipment is delivered as specified in the URS. · Support the North American EHS Manager and other management in environmental activities as required. This includes assisting in the maintenance of the storm water pollution prevention plan, providing storm water training as needed, and assisting in TRI and wastewater compliance. · Support Hoshin teams and A-3 activities OTHER REQUIREMENTS: Essential : · 7 years relevant experience in a regulated pharmaceutical industry with 5 years in a validation role · Bachelor of Science in science or related field · Knowledge of validation strategies and execution techniques, validation requirements and regulatory expectations for GMP compliance. · Familiarity with maintenance processes, PM management and general equipment operations. · Must possess strong customer focus and quality mind set. · Is a champion of compliance while balancing business results · Strong command of the English language; written and orally Desirable: · Master’s degree in science or related field · Blue Mountain calibration and asset management system experience Job Type: Full-time Pay: $67,515.08 - $85,000.00 per year Benefits: 401(k) Dental insurance Health insurance Vision insurance Experience level: 7 years Schedule: 8 hour shift Monday to Friday Work setting: In-person Ability to commute/relocate: Le Sueur, MN 56058: Reliably commute or planning to relocate before starting work (Required) Experience: Pharmaceutical industry: 5 years (Required) validation: 5 years (Required) regulatory: 5 years (Required) GMP compliance: 4 years (Required) Work Location: In person