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Process and Validation Engineer

2 months ago


Marlborough, Wiltshire, United Kingdom Archers Recruitment Full time

Key Responsibilities:

  1. Develop and implement new equipment specifications, sourcing, and validation strategies to ensure compliance with regulatory requirements.
  2. Conduct process and product validation to ensure quality and safety standards are met.
  3. Create concept drawings and technical drawings to support product development.
  4. Identify and troubleshoot process faults, providing technical support to resolve issues.
  5. Develop and maintain manufacturing process records and work instructions.
  6. Generate technical reports and provide training to staff on new processes and procedures.
  7. Manage projects from conception to completion, ensuring timely and within-budget delivery.
  8. Develop and maintain technical documentation, including protocols, lab records, and design history files.

Essential Skills:

  1. Excellent communication and interpersonal skills to work effectively with global teams.
  2. Ability to work in a fast-paced environment with multiple priorities and deadlines.
  3. Strong technical knowledge and skills, including CAD and other relevant software.
  4. Commercial awareness and ability to make informed decisions.
  5. Ability to work independently and as part of a team.

Essential Experience:

  1. Minimum 5 years of experience in the medical device industry, with a focus on process development, test methods development, and protocol writing.
  2. Proven track record of developing and executing design validation protocols and reports.
  3. Experience with statistical methodologies and data analysis.
  4. 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.