Operations Lead Biotech NPI - Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site Based
Pay: €35 - €45 per hour
Experience: 3+ years
Visa: EU passport or Stamp 4 visa required
Operations Lead Biotech NPI - Dun Laoghaire, Dublin
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects.
This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.
They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.
This role is primarily based on-site in Dun Laoghaire.
Function as the site interface between the Product Delivery Teams (PDT’s), and ADL Manufacturing operations.
Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection
Develop, review and update Production, Engineering, Operating Procedures & training materials
Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing
Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
Provide troubleshooting support throughout the project and on the floor during execution of activities
Hold people to account for delivery and behaviors within the Manufacturing Support team and associated with the project(s)
Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects
Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences
Develop, review and update Protocols for manufacturing activities
Documentation and approval of protocol deviations for manufacturing activities
Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner
Own and lead change controls as required by the Manufacturing support team
Review and approve Bills of Materials
Develop, review and update Product Quality Risk Assessments
Requirements
Bachelor’s degree in a science discipline.
3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Strong Project Management and organizational skills, including ability to follow assignments through to completion
Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
Negotiation and Influencing skills
Take initiative to identify and drive improvements
Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
Escalate issues professionally and in a timely manner
Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area
Teamwork and Coaching others
Ensures compliance within regulatory environment
Demonstrated ability to work independently and deliver right first-time results under minimal direction
Package
Contract role - Hourly rate €35 - €45 per hour, 20% shift premium
Minimum 12 month contract with the possibility of an extension.
Shift Patterns & On-Call Opportunities:
Now they have a lot of PPQ activities coming up due to the new vile line we’ll be asking for volunteers for a 3-to-4-week period for the PPQ’s.
There will be volunteers to go on the two-cycle shift pattern & then the other ask is, if you’re not going on the shift pattern can you do on-call for the weekends.
People required to go on a two-cycle shift pattern for the duration of each PPQ activities:
8 hour days operating over a 5 day week (Monday – Friday).
2 week rota.
Week 1 Morning Shift: 07:00 – 15:00 (Mon – Thurs) 07:00 – 14:00 (Fri).
Week 2 Evening Shift: 14:30 – 22:30 (Mon – Thurs) 13:30 – 20:30 (Fri).
Alternating pattern, so if on morning shift week 1 then on evening shift week 2 and so on.
20% shift premium applied.
On-Call
On-call cover for weekends from 07:00 Saturday – 19:00 Sunday (excluding nights).
Rostered on-call.
Must be able to attend site if required over both days.