Senior Validation Engineer
4 weeks ago
Millstone Medical Outsourcing is seeking a highly skilled Senior Validation Engineer to join its Engineering team. As a key member of the team, you will be responsible for leading the validation process to ensure compliance with regulatory requirements and industry standards.
Key Responsibilities:- Develop and implement validation strategies for equipment and processes
- Conduct process analysis and improvements, including equipment and process validations (IQ, OQ, PQ)
- Generate clear and concise work instructions, test methods, and visual standards
- Interface with customers on technical issues, project timelines, and validation support
- Lead cross-functional teams and provide technical support for operations
- Develop and maintain re-validation programs with a risk-based approach
- Facilitate and/or support validation training, project management activities, and change management
- Bachelor of Science in Mechanical Engineering, Chemical Engineering, or Bioengineering with 5-8 years of engineering experience
- Experience in managing and executing projects
- Strong interpersonal and organizational skills
- Excellent leadership and project management skills
- Ability to apply fundamental engineering principles to resolve issues
- Ability to apply working knowledge of applicable regulatory standards and good understanding of GMP requirements and validation processes
- Competitive salary and benefits package
- Opportunities for career growth and development
- Collaborative and dynamic work environment
- Professional development opportunities
Millstone Medical Outsourcing is an equal employment opportunity employer and welcomes applications from diverse candidates. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
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