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Process and Validation Engineer
2 months ago
Key Responsibilities:
- Develop and implement new equipment specifications, sourcing, and validation strategies to ensure compliance with regulatory requirements.
- Conduct process and product validation to ensure quality and safety standards are met.
- Create concept drawings and technical drawings to support product development.
- Identify and troubleshoot process faults, providing technical support to resolve issues.
- Develop and maintain manufacturing process records and work instructions.
- Generate technical reports and provide training to staff on new processes and procedures.
- Manage projects from conception to completion, ensuring timely and within-budget delivery.
- Develop and maintain technical documentation, including protocols, lab records, and design history files.
Essential Skills:
- Excellent communication and interpersonal skills to work effectively with global teams.
- Ability to work in a fast-paced environment with multiple priorities and deadlines.
- Strong technical knowledge and skills, including CAD and other relevant software.
- Commercial awareness and ability to make informed decisions.
- Ability to work independently and as part of a team.
Essential Experience:
- Minimum 5 years of experience in the medical device industry, with a focus on process development, test methods development, and protocol writing.
- Proven track record of developing and executing design validation protocols and reports.
- Experience with statistical methodologies and data analysis.
- Knowledge of FDA/ISO Quality System Requirements and experience working in a regulated environment.
Essential Qualifications:
Bachelor's degree in a life science or related field, such as engineering or biotechnology.