Job Summary: The Validation Specialist will play a critical role in supporting the qualification and validation processes for new manufacturing cell equipment within a medical devices industry. This position ensures compliance with regulatory requirements, industry standards, and internal quality systems to maintain the highest levels of product safety and efficacy.  Project period: May - December 2025.

Key Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for new manufacturing equipment.

• Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure seamless equipment qualification.

• Perform risk assessments and identify critical control points in the validation process.

• Analyze validation data, identify trends, and recommend improvements to enhance equipment performance and compliance.

• Prepare comprehensive validation documentation, including protocols, reports, and standard operating procedures (SOPs).  Weekly written progress report is required.

• Ensure all validation activities comply with regulatory requirements (e.g., FDA, ISO 13485) and industry best practices.

• Support troubleshooting and resolution of validation-related issues (deviations) during equipment / process qualification / validation.

• Maintain up-to-date knowledge of validation standards, guidelines, and technological advancements in the medical devices sector.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.

• Minimum of 3 years of experience in validation within a regulated industry, preferably medical devices or pharmaceuticals.

• Strong understanding of validation protocols, including IQ, OQ, and PQ.

• Familiarity with regulatory requirements such as FDA, ISO 13485, and GMP.

• Excellent analytical, problem-solving, and technical writing skills.

• Ability to work collaboratively with cross-functional teams and manage multiple projects simultaneously.

• Proficiency in validation tools and software is a plus.

Key Competencies:

• Attention to detail and a commitment to quality.

• Strong organizational and time management skills.

• Effective communication and interpersonal abilities.

Work Methodology:

• 100% on site job
• Professional services agreement
• 6 months of project duration
• 3 openings
• Administrative shift from Monday to Friday, 8am to 5pm.