Process Engineer
Claran Consultants
Shanbally, Cork
Apply
JOB DETAILS
LOCATION
Shanbally, Cork
POSTED
30+ days ago
• Provision of technical engineering support to Drug Product Filling operations including process performance monitoring, troubleshooting process investigations and process optimisation.
• Fulfil system ownership responsibilities for assigned Drug Product Filling equipment including production recipe and cleaning recipe updates where required.
• Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products.
• Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables and support qualifications as required.
• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimisation using tools such as DMAIC, SMED and FMEA.
• Provide coaching and support to the Drug Product Filling Operations and Process Engineering team to build their knowledge.
• Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities.
• Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly.
• Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
• Work collaboratively to drive safe, high quality, and cost-effective manufacturing facilities.
• Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
• Ensure adherence to high standards of quality and support of a science and risk-based quality culture.
• Ensures that all manufacturing methods and practices are consistent with industry standards.
• Maintains professional and technical knowledge by attending workshops, reviewing professional publications, establishing professional networks, and participating in professional societies.
• Other duties as assigned.
Education and Experience
• BA Degree in Engineering - Process, Chemical, Mechanical or equivalent discipline
• Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework
• 5-8 years of leading engineering initiatives in a GMP/GCP compliant environment. Biopharma operations experience required.
• 3+ years of directly related experience in Filling Operations.
• Strong knowledge on cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
• Experience with change control process and implementing change on engineering systems.
• Demonstrated ability to partner with other functional groups to achieve business objectives required.
• Superior communication skills – Oral, written and formal presentation skills with senior management, middle management, and line staff.
• Creative problem-solving skills.
About the Company
C