Validation Engineer

PURPOSE
The Validation Engineer is responsible for ensuring that manufacturing processes, equipment, and cleaning procedures meet regulatory standards and consistently produce high-quality products. The engineer will design, execute, and document validation activities for cleaning processes, manufacturing equipment, and production processes.

DUTIES AND RESPONSIBILITIES
Their main duties and responsibilities include:
Write and revise validation documentation, including protocols, reports, SOPs, and risk assessments.
Maintain an up-to-date knowledge of industry standards, regulatory requirements, and best practices.
Provide validation support for change control activities.
Participate in internal and external audits as a validation subject matter expert (SME).
Provide training and support to other departments on validation principles and practices.
Implement and monitor process improvements and corrective actions
Develop, review, and execute cleaning validation protocols and reports for manufacturing equipment, including Clean-in-Place (CIP) systems.
Determine appropriate cleaning cycles, cleaning agents, and acceptance criteria.
Perform sampling and testing to verify the effectiveness of cleaning procedures.
Analyze and interpret cleaning validation data.
Investigate deviations or out-of-specification results related to cleaning validation.
Develop and execute process validation protocols to demonstrate process capability and consistency.
Collaborate with cross-functional teams to identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
Perform data analysis and trending to ensure processes remain in a validated state.
Prepare validation reports and maintain the validation master plan.
Develop and execute equipment validation protocols (IQ, OQ, PQ) for manufacturing and laboratory equipment.
Ensure equipment is properly installed, calibrated, and maintained.
Conduct risk assessments related to equipment and systems.
Review and approve vendor-supplied documentation.
Troubleshoot and resolve equipment qualification issues.

KNOWLEDGE, SKILLS, AND ABILITIES
This position requires a solid combination of technical knowledge, practical skills, and inherent abilities. A candidate should be able to work independently, within a team environment, and possess a high level of professionalism.

MINIMUM QUALIFICATIONS
Bachelor s degree in Life Sciences, Engineering, or a related field.
Minimum of 5 years of experience in validation within a regulated industry (pharmaceutical, biotechnology, medical device, etc.).
Thorough knowledge of cGMP regulations and guidelines.
Experience with cleaning validation, process validation, and equipment validation.
Strong protocol and report writing skills.
Proficiency in data analysis and statistical methods.
Excellent communication, interpersonal, and problem-solving skills.
Proficiency with relevant software applications (e.g., Microsoft Office, data analysis software)

SPECIAL FACTORS/WORKING ENVIRONMENT

TRAVEL
Travel may be required for this position.

WORK ENVIRONMENT
This position works within an GMP Manufacturing Environment, office environment and inside the plant.
o Must be able to work in controlled environments requiring special gowning.
o Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over head, face, and hands, and arms.
o No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
o Pace may be fast and job completion demands may be high.