What are the responsibilities and job description for the Regulatory Affairs Engineer position at Germer International - Pharmaceutical Recruiting?
As a Validation Engineer II at Germer International - Pharmaceutical Recruiting, you will be responsible for conducting thorough validation studies on manufacturing and packaging equipment, pharmaceutical utilities, and other critical systems. Your expertise in qualification and validation protocols, risk assessments, and change control procedures will play a crucial role in maintaining compliance with FDA, ISO, EU, and ICH guidelines.
This role requires a strong understanding of cGMP practices, experience in manufacturing, packaging, and lab equipment qualification, and a proven track record of successfully mentoring junior engineers. If you are passionate about delivering high-quality results and driving process improvements, we encourage you to apply for this exciting opportunity.
Responsibilities:
- Conduct thorough validation studies for manufacturing and packaging equipment
- Develop and execute qualification/validation protocols
- Analyze results and generate final reports
- Mentor junior engineers and coordinate projects with validation contractors
- Create and review risk assessments
- Manage project timelines and ensure change control compliance
Requirements:
- Bachelor's degree
- 3 years' experience in pharmaceutical validation activities
- Knowledge of FDA, ISO, EU, and ICH industry guidelines and cGMP practices
- Experience in manufacturing, packaging, and lab equipment qualification is a plus
