Validation Engineer Galaxypharma Albany, NY Job Details Full-time $40,000 - $80,000 a year 7 hours ago Qualifications Leading team collaboration initiatives Data-driven problem-solving Air conditioning Full Job Description Job Overview We are seeking a highly motivated and detail-oriented Validation Engineer to join our dynamic manufacturing team. In this role, you will be responsible for developing, executing, and overseeing validation protocols to ensure that manufacturing processes, equipment, and systems meet stringent quality standards and regulatory compliance requirements. Your expertise will help drive continuous improvement in product quality, safety, and efficiency across production lines. This position offers an exciting opportunity to contribute to innovative manufacturing environments where precision and compliance are paramount. Responsibilities Develop comprehensive validation plans, protocols, and reports aligned with industry standards such as GMP (Good Manufacturing Practice), ISO 13485, FDA regulations, and other regulatory requirements. Execute validation activities including process validation, equipment qualification (IQ/OQ/PQ), cleaning validation, and software validation to ensure operational integrity. Collaborate with cross-functional teams—including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs—to facilitate smooth validation processes and resolve issues promptly. Conduct thorough quality audits and inspections to verify adherence to established quality standards in production environments. Analyze validation data to identify trends or deviations; implement corrective actions to optimize manufacturing processes. Maintain detailed documentation of validation activities in compliance with regulatory standards and company policies. Lead or support continuous improvement initiatives utilizing methodologies such as Six Sigma and Lean management to enhance process efficiency and product quality. Qualifications Bachelor's degree in Industrial Engineering, Mechanical Engineering, Biotechnology, or a related field; advanced certifications in Validation or Quality Management are a plus. Experience in HVAC is required Proven experience practicing in an industrial or manufacturing engineering role within regulated environments such as pharmaceutical, medical device, or food industries. Strong knowledge of quality systems including HACCP (Hazard Analysis Critical Control Point), CGMP (Current Good Manufacturing Practice), ISO 9001, ISO 13485, and FDA regulations. Familiarity with quality audits, quality control procedures, and regulatory/legal compliance standards in production settings. Expertise in validation tools such as GAMP (Good Automated Manufacturing Practice), GD&T (Geometric Dimensioning & Tolerancing), and GMP protocols. Demonstrated ability to lead teams effectively while fostering cross-functional communication and collaboration. Analytical skills with a keen eye for detail; capable of interpreting complex data sets to inform decision-making. Strong understanding of quality assurance principles including QA/QC practices, risk management, and regulatory compliance standards. Join us to be part of a forward-thinking organization committed to excellence in manufacturing! Your expertise will help ensure our products meet the highest safety and quality standards while supporting innovation and growth within our industry-leading team.

Pay:

$40,000.00 - $80,000.00 per year

Work Location:

In person