- Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP).
- The primary responsibility will be Cleaning Validation.
- Other activities may include Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Process Validation, Change Control, Exception/Event Investigations/Closure.
- Bachelor’s Degree in a scientific/technical discipline required
- Focus on patients and customers at all times.
- 5+ Years Cleaning Validation Experience.
- Experience in a large molecule start-up facility.
- Experience in other Validation areas (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Process Validation).
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities.
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem-solving skills
- Results and performance driven
- Adaptable and flexible
- Integrity, trustworthiness and objectivity
- Knowledgeable of FDA/EMEA regulatory requirements
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org