A GMP Validation Engineer Manager the primary responsibility is to ensure that the manufacturing process and facilities comply with all regulatory requirements and industry standards, including GMP, GLP, and GCP.
The key responsibilities of a GMP Validation Engineer Manager include:
Leading validation activities for new products, processes, equipment, and facilities. This includes developing and executing validation protocols, reviewing and analyzing data, and preparing validation reports.
Providing guidance and oversight to validation engineers, validation specialists, and other personnel involved in the validation process.
Collaborating with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs, to ensure that all validation activities are conducted in compliance with regulatory requirements and industry standards.
Developing and maintaining the site validation master plan, which outlines the site's validation strategy, scope, and timelines.
Leading the review and approval of change control requests, deviations, and investigations related to the validation process.
Conducting risk assessments to identify potential areas of non-compliance and implementing corrective actions as needed.
Providing training to personnel on GMP and validation principles and practices.
Staying up-to-date with industry trends and regulatory changes and implementing best practices as appropriate.
Qualifications include:
Bachelor's degree in Engineering, Science, or a related field.
At least 5-7 years of experience in validation, quality assurance, or a related field, preferably in the pharmaceutical or medical device industry.
Strong knowledge of GMP, GLP, and GCP regulations and industry standards.
Excellent project management skills, including the ability to lead cross-functional teams and manage multiple projects simultaneously.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Experience with validation software, such as LIMS or Trackwise, is preferred.
