Senior Technical Operations Engineer
Life Science Recruitment
- Cork
- Contract
- Full-time
RK8749
Contract – 12 months
CorkWe’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:Cleaning Compliance:
- Responsible to ensure site cleaning practices are in line with external auditing requirements.
- Serve as the Subject Matter Expert (SME) for cleaning compliance activities on site.
- Mobilize cross-functional teams to ensure local SOPs are in line with Global and external agency requirement. Update procedure as required.
- Monitor and trend cleaning deviations and develop yearly action plans to improvement performance.
- Led the cleaning improvement projects on site, clearly displaying progress on projects in projects
- Support the investigation leads on day to day cleaning issue ensuring CAPA prevent recurring items.
- Participate or Lead the Cleaning Community of Practice, working across API sites
- Collaborate with internal and external stakeholders, including Compliance Owners to support investigations /improvements, change controls, and CAPA development.
- Lead complex investigations with cross-functional teams, applying analytical and problem-solving skills to determine root causes, assess impacts, and implement process improvements.
- PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.
- Minimum of 2 years of experience in a similar role within the pharmaceutical industry or equivalent.
- Previous API cleaning experience in deviation management and/or API cleaning compliance.
- Strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.