Supporting site Capital & Expense projects on site. Reporting to the Site Projects Lead, the incumbent will be responsible for the change management for several site-based projects.
• Link with project team to develop project change control document.
• Review any queries that may arise from project change control committee.
• Generate action list and assign actions on track-wise and review until closure.
• Review equipment list with project team and issue request for tag numbers.
• Complete equipment registration forms.
• Compile CCR’s for equipment, instrumentation, pipe work and bonding, print the approved copies from MIDAS.
• Ensure Handover Packs from vendor/contractors contain the required information – issue deadline date to vendor/contractors for packs.
• Compile change control packs and circulate for approval.
• Prepare Documentation Handover Section – (warranty etc.)
• Implementing equipment onto the asset register via SAP.
• Commission and Qualify (C&Q) various process and laboratory equipment.
• Design and execute process validation studies for the large Scale API processes.
• Review and assess change control for API processes to determine impact on validated state.
• Apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
• Participate in efficiency and streamlining projects contribute to process improvement, technology transfer, new product introduction and other projects.
• Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
• Requires degree in Mechanical or Chemical Engineering. Pharmaceutical/biotech experience, sterile manufacturing C&Q experience a plus.
• 5+ years’ relevant work experience.
• Experience working in Pharm/Bio Pharm industry with experience in project activities in maintenance, engineering and project management practices.
• Experience of using SAP and advantage.
• Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
• Familiar with engineering project management tools.
• Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
• High level of customer orientation/understanding.
• Strong interpersonal skills and an understanding of the customer/client relationship involved in project management.
• Excellent communication /presentation skills.
• Superior organizational and planning skills.
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