דרושים Npi / Tech Transfer Manager ב-Msd ב-אירלנד

Job Description

Key responsibilities will include:

• Design/Author/Review/Approve/Execute process development studies.
• Manage multiple New Product Introduction (NPI)/Tech transfer projects to ensure smooth delivery of new products from other sites at our highly automated Carlow facility.
• Drive business goals through effective team leadership, cross-functional relationship development, and the application of technical knowledge to support continuous improvement and troubleshooting.
• Expand and develop the tech transfer team at Carlow by providing effective coaching and management for continuous professional development.
• Provide technical leadership to subject matter experts within the team on topics such as drug product process and equipment validation, tech transfer, and compliance.
• Promote a data-driven continuous improvement mindset within the technical engineering team, utilizing tools such as Structured Root Cause Analysis, Statistical Process Control, and Data-driven decision making.
• Foster collaboration between groups, seeking synergies and innovative ways of working. Continuously assess systems and processes to identify opportunities for improvement, working smarter and more efficiently while remaining compliant.
• Act as a liaison with global teams, facilities, and specialist vendors to ensure timely and successful project delivery as required by the business.
• Ensure ongoing compliance with the company's Global Policies, Procedures, Guidelines, and regulatory requirements.
• Collaborate to drive a safe and compliant culture in Carlow.

Your profile:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other technical discipline
• Minimum Bachelor's Degree in a relevant science or engineering discipline. Advanced qualifications are a plus.
• Considerable experience in a comparable role in the pharmaceutical or biotechnology sector. Sterile filling experience is highly advantageous.
• Process engineering and/or validation experience/or technical operations.
• Proven track record of effectively leading high-performing teams of engineers/scientists through technical transfer and change projects.
• Strong knowledge of working in highly automated environments with an understanding of interfaces between drug product equipment and systems such as Delta V, MES, etc.

So, if you are ready to:

Current Contingent Workers apply

Applied Engineering, Applied Engineering, Budget Management, Cleanroom Validation, Engineering Principle, Engineering Standards, Estimation and Planning, Global Team Collaboration, Maintenance Management, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Motivational Coaching, New Product Development, New Product Introduction Process, People Leadership, Performance Coaching, Process Engineering, Professional Development, Project Delivery, Regulatory Compliance, Regulatory Requirements, Report Writing, Safety-Oriented, Success Coaching {+ 4 more}

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Execute complex maintenance tasks on Site Services and production equipment, ensuring high availability and reliability.
• Act as the primary technician for diagnosing and resolving intricate issues related to site services, utilizing advanced diagnostic tools and techniques.
• Lead the investigation and resolution of quality events related to site services GMP equipment, ensuring compliance with regulatory standards and documentation in the Quality Management System.
• Be part of the ERT team and act as deputy ERT Lead.
• Responsible for Raising of Enablon actions in response to site EM (Emergency) incidents and follow to closure.
• Performing and support equipment isolation of system including electrical equipment.
• Monitoring control systems for alarms, investigating issues, performing preventative and corrective maintenance, and ensuring high plant uptime.
• Collaborating with vendors, conducting field rounds, maintaining safety and housekeeping standards, and participating in training and procedural reviews, all while working as part of a flexible, multi-functional team.
• Creation of GMP documentation which includes WI, SOPs and Forms
• Act as Site service area owner managing the Permit to Work system and conducting vendor review assessments.
• Operate and maintain WWPT.
• Ensure all equipment and processes comply with statutory and regulatory requirements, conducting regular audits and assessments.
• Collaborate with engineering teams on new project initiatives, providing technical expertise during commissioning and qualification activities.
• Deliver training on specialized equipment and maintenance procedures to junior technicians and new hires.
• Supervise junior technician and new hire work where necessary.
• Act as an SAP Gatekeeper out of hours for any requested EM works.
• Perform contractor evaluation for all works carried out on equipment and areas owned by the site services team.
• Support all Sampling activities related to Site Services systems including WFI & Process gasses.
• Support all vendor visits related to Site Services
• Perform site walks to verify EHS and Quality standards are adhered.
• Maintain and troubleshoot site services systems on GMP manufacturing floor to support safe and efficient production operations.
• Manage, maintain, and optimise the unique utility systems of each Dunboyne building to ensure seamless operation and compliance with safety and efficiency standards.
• Provide the necessary cover and expertise across two Dunboyne buildings.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Trade Certificate, City & Guilds or equivalent in Mechanical / Electrical / Instrumentation discipline.
• At least 3-4 years’ experience in managing and optimizing utilities systems in manufacturing environment.
• Good knowledge of Systems including HVAC, Steam, water, Process gases, Clean Steam, Water for Injection, Chilled water systems, CTUs Wastewater system and fire systems.
• Strong computer skills
• Electrical Qualification desirable.
• Excellent communication, interpersonal, and team-working skills.
• Good understanding of the operation of automated and control systems
• Ability to work independently and as a member of a team in a dynamic, fast-paced environment.
• Strong technical problem-solving abilities.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

Computerized Maintenance Management Systems (CMMS), Computerized Maintenance Management Systems (CMMS), Computer Literacy, Corrective Maintenance, Electrical Maintenance, Equipment Commissioning, Equipment Maintenance, Fire Safety Systems, GMP Compliance, HVAC Systems, Hydraulic Systems, Instrumentation Systems, Instrument Calibrations, Maintenance Processes, Maintenance Scheduling, Managing Engineering Teams, Manufacturing Compliance, Mechanical Maintenance, Permit to Work Systems, PLC Programming, Pneumatic Systems, Preventive Maintenance, Quality Control Documentation, Quality Management, Quality Systems Documentation {+ 5 more}

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Current Contingent Workers apply

Language(s) Job Description:

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.