Validation Engineer

A leading global manufacturer, marketer and distributor of animal health products and veterinary pharmaceuticals

We have a caring, family culture which ensures employees feel supported in their personal and professional lives. We work through challenges together and provide a working environment where people feel valued and where they can learn and grow within our business

The Validation Engineer/Manager is responsible for the execution and regulatory compliance of the validation program. The Validation Manager is well-versed in the generation, execution, modification, and summation of Validation documents to ensure Good Documentation Practices within pharmaceutical operations. This role serves to ensure products and processes are maintained in a validated state and compliant with regulatory and cGMP requirements throughout the product lifecycle. This is accomplished through interaction and coordination of activities with all relevant departments within the organization.

Essential Requirements
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.

KEY ROLE SPECIFIC REQUIREMENTS:

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