Job Description
Kenny-Whelan (a specialist division of the CPL group) are hiring aCLEANING VALIDATION SPECIALIST -APIto work on contract atJanssen Sciencesin Little Island Cork ContactJenn Dinan on or email New Vacancy: Sept 2024 MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it Cleaning Validation Specialist- - bulk active pharmaceutical ingredients (APIs) MUST HAVE Pharmaceutical API Process expertise If you have cleaning validation but only from biopharma or vaccines you will not be considered We are recruiting someone with expertise with Robust Cleaning Validation process for bulk active pharmaceutical ingredients Manufacturing in Pharmaceutical Plant This is a critical hire for the site with long term scope for the right candidate Responsibilities 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 Janssen 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 Janssen Cleaning Community of Practice, working across 4 API sites in the Janssen API network. INVESTIGATIONS AND INNOVATION: 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. REQUIREMENTS 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. Excellent communication and collaboration skills, with the ability to lead cross-functional teams and drive process improvement initiatives. Demonstrated leadership abilities, including experience in project management and team coordination. Skills: API Chemical process Pharmaceutical Cleaning Validation chemical engineering Benefits: parking Staff Discounts