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Freelance Lead Validation Engineer
2 months ago
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
Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
James Gregory
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