Kindeva Drug Delivery
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Validation Engineer
role at
Kindeva Drug Delivery
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 the 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 Master’s degree
Preferred Qualifications:
Previous work experience in a 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
Regularly use hands to handle materials and supplies
Use computers for extended periods
Effective communication by telephone and electronic means
Regularly stand and walk for extended periods
Occasionally lift and/or move up to 25 pounds
Use proper lifting techniques and be conscious of work area hazards
Follow all site safety procedures
Notice for California Employees and Applicants
| California residents should review our notice before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr
Validation Engineer
role at
Kindeva Drug Delivery
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 the 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 Master’s degree
Preferred Qualifications:
Previous work experience in a 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
Regularly use hands to handle materials and supplies
Use computers for extended periods
Effective communication by telephone and electronic means
Regularly stand and walk for extended periods
Occasionally lift and/or move up to 25 pounds
Use proper lifting techniques and be conscious of work area hazards
Follow all site safety procedures
Notice for California Employees and Applicants
| California residents should review our notice before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr