Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
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A bit about us:
A leading global manufacturer, marketer and distributor of animal health products and veterinary pharmaceuticals
Why join us?
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
Job Details
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
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According to the United States Census Bureau, the city has a total area of 37.83 square miles (97.98 km2), of which 36.06 square miles (93.39 km2) is land and 1.77 square miles (4.58 km2) is water. Lakeville includes the Argonne Farms post-World War I settlement project which failed in the early 20th century and was redeveloped in the 21st century into typical suburban retail. Since it was a semi-autonomous village within Lakeville Township before the city's incorporation, it continues to appear today on maps as Argonne.
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Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$59,009 to $78,824
Lakeville, Minnesota area prices were up 1.4% from a year ago