Main Responsibilities

• Develop or modify validation packages and deliverables (assessments, plans, requirements, protocols).
• Report unexpected validation events or issues to project team and management.
• Use systematic problem-solving to resolve validation issues.
• Oversee and approve equipment, process, and validation documentation and change control records.
• Ensure documentation accuracy, clarity, consistency, completeness, and compliance.
• Drive FUE and process validation strategies for new or modified products, processes, facilities, and equipment.
• Incorporate procedures, controls, and recovery plans into implementations/changes.
• Collaborate with cross-functional teams to ensure quality and compliance.
• Meet validation schedules aligned with project goals.
• Work independently with objectives from the Quality Manager.
• Plan and coordinate work per higher-level project schedules.
• Support investigations and resolution of product/process nonconformances and CAPA.
• Identify and support process improvement opportunities.
• Provide coaching and mentoring to team members and colleagues.
• Participate in or lead quality teams and support divisional initiatives.
• Perform other related duties as assigned.

Qualifications

• Education: Bachelor's Degree in Engineering or Technical Field, or equivalent education and work experience.
• Experience:
  • Minimum 5 years in medical device/pharmaceutical manufacturing.
  • Process Validation and use of Quality tools/methodologies.
  • Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Skills:
  • Strong written and oral communication.
  • Project management and leadership.
  • Medical device validation (preferred).
  • Implementation of product/process improvement (Six Sigma, Lean Manufacturing).
  • Teamwork and individual contribution in fast-paced environments.
  • Effective communication at multiple organizational levels.
  • Multitasking, prioritization, and meeting deadlines.
  • Organizational skills and attention to detail.
  • Regular and predictable attendance.

Please send your resume to James.Gregory@darwinrecruitment.com