Chief Validation Officer
2 weeks ago
We are seeking a highly skilled validation engineer to join our global validation team within the worldwide engineering organization. This role is pivotal in characterizing, optimizing, and validating complex manufacturing equipment and processes.
Key Responsibilities:
- Lead validation projects using lean strategies and project management tools.
- Drive cross-functional collaboration to meet project milestones and ensure stakeholder alignment.
- Identify and implement process improvements using Six Sigma, Lean, and technical design methodologies.
- Design and execute complex experiments and validation protocols, analyze data, and generate reports.
- Develop and execute validation protocols (CQ, IQ, OQ, PQ, TMV, software validation).
- Conduct engineering studies to assess process variability and define acceptance criteria.
- Manage software/hardware validation with traceability to user/system requirements.
- Recommend and implement enhancements to validation systems for improved compliance and efficiency.
- Train and mentor engineers and technicians on validation best practices.
- Maintain and update training materials and production documentation.
Requirements:
- Bachelor's degree in engineering or scientific disciplines with at least 4 years of relevant experience; or
- Master's degree in engineering or scientific disciplines with at least 3 years of relevant experience; or
- Ph.D. in engineering or scientific disciplines with no experience.
- Experience with validations (i.e., process, equipment, or facility validations)
- Experience working in a highly regulated industry
Preferred Qualifications:
- Medical device, biotechnology, or pharma industry experience
- Expertise in process validation, equipment qualification, and regulatory compliance.
- Experience with digital validation platforms (e.g., Kneat, Veeva, Valgenesis, or JAMA).
- Familiarity with process automation, measurement system analysis (MSA), and advanced manufacturing technologies.
- Strong knowledge of cGMP, medical device regulations, EHS, and cleanroom manufacturing standards.
- Proficiency in statistical tools (e.g., Minitab) and technical writing.
- Strong analytical, problem-solving, and communication skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Leadership and change management experience.
- Certifications: Six Sigma, CQE, or equivalent.
- Proficiency in MS Office Suite (including MS Project).
What We Offer:
- Competitive salaries
- Performance-based incentives
- A wide variety of benefits programs
Other Requirements:
- COVID-19 vaccination
- Work permit required for non-EU citizens
This role requires a strong understanding of validation principles, regulations, and industry standards. The ideal candidate will have experience working in a highly regulated industry and be proficient in lean strategies and project management tools.
The successful candidate will be responsible for leading validation projects, driving cross-functional collaboration, and implementing process improvements. They will also be expected to develop and execute validation protocols, conduct engineering studies, and train and mentor engineers and technicians.
Our company offers a competitive salary, performance-based incentives, and a wide variety of benefits programs. The successful candidate will also be required to undergo COVID-19 vaccination and obtain a work permit if they are not an EU citizen.
Job Title Example:Senior Engineer, Global Validation
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