We are seeking a Senior Manufacturing Engineer to join our client, a major name in the medical device field, on a contract basis. The ideal candidate will be a hands-on, detail-oriented engineer with a strong background in the medical device industry. This role will provide advanced technical and engineering support to a critical project focused on the validation of a new cleaning process for our medical device manufacturing line. The successful candidate will be a key contributor, ensuring the project meets all quality, regulatory, and performance objectives.
Key Areas of Responsibility
- Execute key validation activities, including Equipment Qualification (EQ), Process Characterisation, and Process Qualification (PQ), to support the new cleaning process.
- Conduct statistical analysis of process data and prepare documentation to ensure all user requirements are met.
- Work with state-of-the-art equipment, including an ultrasonic bath, CNC machines, and other solvent-based cleaning systems.
- Develop and implement appropriate supporting documentation, including Standard Operating Procedures (SOPs) and work instructions, in compliance with Good Manufacturing Practices (GMP).
- Provide technical leadership on all product and process-related issues, troubleshooting and resolving issues with a focus on continuous improvement.
- Collaborate with cross-functional teams and external vendors to ensure project milestones are met on time and within budget.
- Act as a Subject Matter Expert for regulatory audits and provide out-of-hours support when required.
- Monitor line performance, proactively identifying and resolving issues to ensure optimal efficiency.
- Transfer and implement processes from development to a full-scale manufacturing environment.
Qualifications, Knowledge, and Skills
- Level 8 Degree in Mechanical Engineering or a related technical discipline.
- 2-4 years of experience in a manufacturing or engineering role within the medical device or pharmaceutical industry.
- Demonstrable experience with validation processes (IQ, OQ, PQ) is essential.
- Proven ability to conduct statistical analysis and interpret process data.
- Experience with cleaning processes, particularly solvent-based systems, is a significant advantage.
- Knowledge of sterilisation processes is also a plus.
- Excellent project management and problem-solving skills, with a results-oriented mindset.
- Strong communication and interpersonal skills, with the ability to influence and provide technical direction to a team.
- Capable of working autonomously and as part of a multi-disciplinary team in a fast-paced environment.
- A team player with a flexible approach and a focus on continuous improvement.
