Sr. Validation Engineer
Sr. Validation Engineer
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Salary Not Disclosed
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.
Our Work Matters
At Kindeva we make products that save lives ensuring better health and well-being for patients around the world.
As a Sr. Validation Engineer you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activitiesincluding equipment utilities facilities and process validationsto ensure our operations remain compliant and inspection-ready. Your expertise in cGMP risk-based validation and technical writing will directly impact the safety efficacy and consistency of the drug products we deliver. This is a highly visible hands-on role ideal for a detail-oriented professional passionate about quality and continuous improvement in a dynamic fast-paced environment
Responsibilities:
Validation Strategy & Execution
- Develop execute and maintain validation protocols and reports (IQ OQ PQ) for equipment utilities and manufacturing processes.
- Support commissioning and qualification (C&Q) activities for new equipment and facilities ensuring compliance with FDA EU and global regulatory expectations.
- Author and review validation lifecycle documentation including plans protocols deviations and final reports.
- Partner with Engineering Manufacturing Quality and Regulatory Affairs to ensure effective cross-functional validation planning and execution.
- Perform periodic reviews and revalidation activities in accordance with lifecycle requirements.
Compliance & Risk Management
- Lead risk assessments (FMEA gap assessments) to determine validation strategy and appropriate testing requirements.
- Provide validation input during change control deviation investigations and CAPA execution.
- Ensure data integrity and good documentation practices in all validation records.
- Act as subject matter expert (SME) during internal and external audits and inspections.
Continuous Improvement
- Evaluate validation program effectiveness and recommend process improvements to enhance compliance efficiency and scalability.
- Stay current with industry best practices and evolving regulatory guidance to ensure validation activities remain aligned with expectations.
Basic Qualifications:
- Bachelors degree in engineering life sciences or a related technical field.
- 5 or more years of validation experience or 3 or more years with a Masters degree in a regulated pharmaceutical biotech or medical device environment.
- Demonstrated knowledge of FDA EU and ICH regulatory requirements including 21 CFR Part 11 and Annex 15.
- Experience in developing and executing validation documentation (IQ/OQ/PQ protocols reports).
- Strong organizational communication and technical writing skills.
- Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment.
Preferred Qualifications:
- Familiarity with validation of automated systems and computerized system validation (CSV).
- Experience with nasal or respiratory drug delivery systems aseptic manufacturing or cleanroom validation.
- Working knowledge of validation tools and systems (e.g. TrackWise ValGenesis Veeva).
- Lean Six Sigma or other continuous improvement training/certifications.
Physical Requirements:
- Vision requirements include: close distance color vision and focus adjustment.
- Employees are required to follow all cGMP and safety procedures.
- Must wear all required PPE and safely perform assigned work.
- Must use proper lifting techniques and be aware of hazards in the environment.
- Must occasionally lift and/or move up to 20 pounds.
Required Experience:
Senior IC
Employment Type
Full-Time
