Role: Technical Operations Specialist
Location: Ringaskiddy, Cork, Ireland
Reports to: Technical Operations Manager
We have an exciting opportunity for a Technical Operations Specialist to join our expanding team in Cork to help support the Technical Operations unit.
The Technical Operations Specialist will be responsible for the following;
Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP). Primary activities are in the Process and Lifecycle Management area. Secondary activities include, but are not limited to:
- Cleaning Validation,
- Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges),
- Manufacturing 2nd Line Support of commercial products,
- Supporting process improvement projects / Commercial Product scale up projects / New technology deployment, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).
What you’re great at:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem-solving skills
• Results and performance driven
• Adaptable and flexible
• Integrity, trustworthiness and objectivity
• Knowledgeable of FDA/EMEA regulatory requirements
As a Technical Operations Specialist, your typical day may include:
• Conduct Technical Operations activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
• Develop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, manual and automated reports).
• Statistically analyze data and troubleshoot problems with other departments.
• Review and approve documents prepared by other Technical Operations colleagues.
• Execute Technical Operations protocols as required.
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• Prepare reports for executed protocols for review and approval.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions/events/deviations during Technical Operations activities.
• Prioritize Technical Operations activities in line with Manufacturing / the particular project schedule.
• Co-ordinate Technical Operations activities with contractors and vendors as required.
• Co-ordinate Technical Operations document review and approval.
• Collate and organize Technical Operations files for turnover to QADC.
• Attend identified training, required to fulfill the role of a Technical Operations Specialist.
• Participate in cross-functional teams as required.
• To Bachelors Degree in a scientific/technical discipline required
• Focus on patients and customers at all times.
• Experience in Manufacturing (e.g. Supporting: Process Improvement Projects / Process Validation campaigns/Root Cause Problem solving/ Statistical data analysis)
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.