Initial 12-month contract role.
The Technical Operations Specialist will be responsible for actively supporting teams and projects initiated to address issues caused by Global Material Shortages due to Covid 19, in particular challenges faced due to Single-Use disposable supply chain constraints. The Technical Operations Specialist will provide technical support to a cross-functional Tiger team (Planning, Procurement, Quality and Technical Operations) addressing challenges impacting base business due to material supply constraints in addition to project workstreams focusing on dual-sourcing and optimization of polymeric Single-Use assemblies and components improving reliability and ensuring continuity of future supply chains.
Role is part of the Tiger team working on Project Boost – team is cross-functional. This Tech Ops sub team has 2-3 people supporting the wider cross-functional team. Primary focus is Process Validation activities.
Boost project: Optimization of Single-Use assemblies and dual-sourcing of constrained components to improve reliability and ensure continuity of future supply chain. Role will provide technical support to Tiger team and Boost project polymeric workstreams.
Attendance at Cork Operations Material response team meetings.
Technical assessment of changes and alternatives to Single-use assemblies and components proposed by vendors.
Risk assessment of changes and proposed mitigations for stocked out materials.
Filter validation, Extractable and Leachable (E&L) Risk assessment.
Liase with Single-Use vendors.
Impact assessment of Change controls.
What you’re great at:
- Excellent interpersonal skills
- Ability to operate as part of a cross-functional team is critical
- Excellent communication skills both written and verbal
- Good problem-solving skills
- Results and performance driven
- Knowledgeable of FDA/EMEA regulatory requirements
As a Technical Operations Specialist your responsibility will be to:
- Conduct Technical Operations activities in compliance with US and EU regulations, company procedures and EHS&S requirements.
- Liaise with Operations Material Response team/Tiger team and Boost project workstreams to provide technical support in a timely manner.
- Technically assess alternatives and changes to Single-Use assemblies and components (eg. SUMs/SUBs/filters) proposed by vendors.
- Participate in cross-functional risk assessment of alternatives proposed to mitigate stocked out materials.
- Assess change controls and implement activities in accordance with site procedures.
- Perform Extractable and Leachable (E&L) Risk assessments.
- Liaise with Single-Use polymeric vendors.
- Co-ordinate validation activities supporting qualification of alternative Single-Use components eg. filter validation testing.
- Attend identified training, required to fulfill the role of a Technical Operations Specialist.
- Level 8 bachelor’s degree in a scientific/technical discipline required
- Experience in Filter validation, Material Qualification and Extractable and Leachables (E&L) Risk assessment.
- Experience in Single-Use Disposable Material Qualification.
- Experience with Change Control and Trackwise.
- Knowledge of Upstream and Downstream large molecule drug substance processes.
- 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.