Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related field.
• 5+ years experience in regulated environments (pharmaceutical, biotechnology, medical device).
• Experience with GMP systems, controlled environments, and validation programs.
• Proficient in authoring and reviewing technical documentation.
• Strong grasp of validation lifecycle concepts and GMP compliance.
• Excellent technical writing, organizational, and communication skills.
• Ability to manage multiple tasks independently.

Responsibilities

• Execute validation lifecycle activities for GMP systems.
• Perform periodic reviews for various systems (EQPR, CTCPR, CSPR, AATR).
• Review and assess deviations, CAPAs, and system performance data.
• Evaluate system changes' impact on validation and compliance.
• Assess systems for ongoing suitability and compliance.
• Author and update periodic review reports and validation documentation.
• Assist in developing and maintaining Validation Master Plans (VMPs).
• Support Annual Product Review activities and summary reports.
• Engage in multidisciplinary discussions with various operational teams.
• Identify compliance risks and areas for operational improvements.
• Mentor junior staff as needed.
• Aid in regulatory inspections and audits.

Benefits

• Flexible hybrid work arrangement.
• Opportunities for professional development and advancement.
• Access to ongoing training and mentorship.
• Collaborative work environment with cross-functional teams.
• Engagement in impactful projects with notable clients.