Original listing text, shown exactly as published by the company.
Key Responsibilities
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
- Ownership of equipment/systems in a GMP regulated manufacturing setting.
- Monitoring of day-to-day performance of their assigned system. Expected to regularly report out on performance and issue resolution plans for all packaging equipment. Anticipating, solving or escalating problems as appropriate.
- Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.
- Proactively identify opportunities for continuous improvement in equipment & processes as well as preventative maintenance support to technicians for regular activities.
- Anticipate issues and plan effective preventative solutions in a timely matter and plan works around a busy manufacturing schedule and defined available resources.
- Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures.
- Ownership of all GMP documentation and their accuracy throughout the lifetime of the equipment (e.g. Risk assessments, Functional Design, User Requirement specifications etc.)
- Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems and follow up to ensure learnings are actioned.
- Collaborate & support the Process & Quality Team in investigations, Non-Conformance and CAPA closure.
- Provide oversight & support the Project Team with equipment upgrades and new equipment introductions, including FAT, SAT & IOQ protocols to ensure changes are fit for purpose and meet business needs.
- Ensuring that a critical spare parts list for their system is identified and appropriate levels of spares are maintained.
- Maintain a structured plan for future improvements and downtime for equipment.
- Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs.
Basic Qualifications
- Bachelor’s degree in engineering (Mechanical, Electrical or Mechatronic preferred)
- Senior level experience of providing technical solutions in the packaging, inspection, medical device or pharmaceutical sector.
- Demonstrated solid leadership, with the ability to build teams and operate across functional boundaries, both internal and external.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Demonstrated experience of vendor management and contract negotiations with focus on equipment suppliers, SLA’s and continuous supplier performance.
- Significant experience large project related activities including GMP qualification experience.
Preferred Experience
- Typically, 5+ years’ engineering experience in an automated packaging or inspection of pharmaceutical, combination products or medical device product environment.
- Experience supporting packaging lines essential. Automation/ serialisation and vision system experience an advantage.
- Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous.
- Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate.
- Independent, self-motivated, organized, able to multi-task in a production environment
- Team player, prepared to work in and embrace a team-based culture that relies on collaboration, support other areas to meet business requirements.
Travel at various times may be required to support execution of projects
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