1 day ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Halian
This is an exciting opportunity to join a Medical Device company with the manufacturing expertise to take new products through initial design and development through to high volume manufacture.
Due to expansion, a new role has been created for a highly skilled & experienced Lead Validation Engineer to join the Operations team in Suffolk. You will play a key role in ensuring the quality, safety, and compliance of the medical devices produced through the validation of manufacturing processes, equipment, and systems.
Key Responsibilities
* Develop, execute, and document validation protocols and reports for manufacturing processes, equipment, cleaning, and sterilisation processes.
* Ensure compliance with relevant regulatory standards such as ISO 13485, FDA and EU MDR.
* Collaborate with cross-functional teams including; Quality Assurance, R&D, Regulatory and Manufacturing to support process improvements.
* Conduct risk assessments and validation lifecycle activities to ensure product quality and manufacturing consistency.
* Participate in audit preparations and support regulatory inspections related to validation activities.
* Maintain validation documentation in accordance with regulatory and company requirements.
Qualifications & Experience:
* Bachelor’s degree in engineering, life sciences or a related field (Chemical, Mechanical Engineering)
* Minimum of 5 years' experience in process validation within the medical device manufacturing industry.
* Strong understanding of validation methodologies (IQ/OQ/PQ) and validation lifecycle.
* Knowledge of regulatory standards (ISO 13485, FDA regulations, EU MDR).
* Experience with risk management tools and techniques.
* Data driven, comfortable using statistical software.
* Excellent problem-solving, communication, and organisational skills.
* Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications:
* Previous experience in a Process Validation role in a CMDO or medical device manufacturer working at volume
* Knowledge of the operation and constraints associated with high-volume automation systems
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Manufacturing
* Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Halian by 2x
Sign in to set job alerts for “Validation Engineer” roles.
Suffolk, England, United Kingdom 1 day ago
Somersham, England, United Kingdom 2 weeks ago
Delivery Quality Engineer - Sizewell C - Ground Engineering Works - Suffolk based
Ipswich, England, United Kingdom 4 days ago
Denham, England, United Kingdom 2 weeks ago
Sproughton, England, United Kingdom 2 days ago
Sudbury, England, United Kingdom 9 months ago
Ipswich, England, United Kingdom 3 months ago
Ipswich, England, United Kingdom 4 weeks ago
Somersham, England, United Kingdom 2 weeks ago
Suffolk, England, United Kingdom 1 month ago
Ipswich, England, United Kingdom 3 months ago
Gillingham, England, United Kingdom 2 weeks ago
Stowmarket, England, United Kingdom 20 hours ago
Ipswich, England, United Kingdom 3 weeks ago
Design Coordinator - Engineering and Assurance / Geotechnical Works / Enabling and Earthworks - Sizewell C - Suffolk site based
Leiston, England, United Kingdom 2 weeks ago
Ipswich, England, United Kingdom 1 day ago
Ipswich, England, United Kingdom 1 month ago
Trainee Coding & Programmer Placement Programme
Lowestoft, England, United Kingdom 2 days ago
Ipswich, England, United Kingdom 7 months ago
Semer, England, United Kingdom 1 week ago
Tan Office, England, United Kingdom 2 weeks ago
Gillingham, England, United Kingdom 9 months ago
Stowmarket, England, United Kingdom 1 week ago
Design Manager - Engineering and Assurance / Geotechnical Works / Enabling and Earthworks - Sizewell C - Suffolk Site based
Leiston, England, United Kingdom 2 weeks ago
Bury St Edmunds, England, United Kingdom 4 months ago
Woodbridge, England, United Kingdom 2 days ago
Bury St Edmunds, England, United Kingdom 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr