Validation Engineer

Role: Validation Engineer supporting equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP environments. Primary objectives include developing, executing, reviewing, and maintaining validation lifecycle documentation to ensure compliance with regulatory standards such as 21 CFR Part 11, data integrity, and GMP regulations. Responsibilities encompass supporting MES and eBR implementation, qualification activities, risk assessments, audit responses, deviation investigations, and system releases. The role involves authoring validation protocols (IQ, OQ, PQ), performing validation activities like thermal mapping, and ensuring operational readiness through qualification and requalification tasks. Requirements include a Bachelor's in Engineering, Life Sciences, or related field, with 4-7 years of validation experience in pharma, biotech, or regulated industries, especially supporting equipment, process, or computerized system validation, including MES support (e.g., PAS-X, Syncade). Preferred skills include familiarity with MES platforms, GMP auditing, and validation methodologies, along with strong technical documentation, analytical, and cross-functional collaboration skills. The position may involve supporting audits, change controls, and validation for manufacturing automation systems. The work environment is primarily office-based with moderate noise levels, with physical demands typical of an office role. Location is flexible, with remote work options, and some travel may be required. The role reports to Quality or Validation leadership and involves partnering across Manufacturing, Quality, Automation, and IT teams to ensure validation excellence in a regulated biotech/pharma setting.