Validation Engineer
Validation Engineer
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1 Vacancy
Job Description
Our Work Matters
At Kindeva we make products that save lives ensuring better health and well-being for patients around the world.
The Impact You Will Make: As a Validation Engineer you will play a key role in supporting the qualification and validation activities that ensure our manufacturing processes and equipment meet rigorous regulatory and quality standards. Your expertise will help maintain compliance with cGMP and industry guidelines contributing to the reliable production of safe and effective pharmaceutical products. You will collaborate closely with cross-functional teams to execute validation protocols and ensure smooth technology transfers.
Responsibilities:
- Develop execute and review validation protocols for equipment processes and utilities in a GMP manufacturing environment.
- Support installation operational and performance qualification (IQ/OQ/PQ) activities to ensure equipment and systems meet design specifications.
- Assist in the development and maintenance of validation documentation including protocols reports and traceability matrices.
- Collaborate with manufacturing quality engineering and other stakeholders to ensure validation requirements are met.
- Participate in risk assessments and change control processes related to validation activities.
- Support continuous improvement initiatives for validation strategies and documentation.
- Ensure compliance with cGMP GAMP5 and regulatory expectations throughout validation lifecycle.
- Communicate validation status and issues effectively through written reports and verbal updates.
- Assist in training team members on validation procedures and standards.
Qualifications:
Minimum Qualifications:
- BS in engineering related degree or equivalent experience
- 4 years of related experience; or 3 years with a Masters degree
Preferred Qualifications:
- Previous work experience in GMP manufacturing environment
- Working knowledge of cGMP GAMP5 and regulatory requirements
- Experience working with nasal spray products devices or related drug-delivery systems
- Effective oral and written communication skills
- Technical writing experience including SOPs maintenance PMs user requirement specifications design qualifications and traceability matrices
- supporting regulatory agency inspections or audits.
Physical Requirements:
- Employee is required to regularly use hands to handle materials and supplies.
- Employee is required to use computers for an extended period each day.
- Employee is required to effectively use communication by both telephone and electronic means.
- Employee is required to regularly stand and walk for extended periods.
- Employee must occasionally lift and/or move up to 25 pounds.
- Ability to use proper lifting techniques and be conscious of work area hazards.
- Employee is required to follow all site safety procedures.
Employment Type
Full-Time
