Pharmaceutical & Biotechnology

Operations Lead

Posted 3 days ago
Contract
South Dublin, County Dublin, Ireland
42134243

PE Global is recruiting for an Operations Lead on behalf of our biopharmaceutical client in Dublin. This is an initial 12-month contract, hybrid role.

Job Summary:

The Operations Team 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.

Primary Responsibilities:

• Ability to take on and lead projects under minimum supervision

• Experience in working in cross function groups

• Knowledge of Aseptic processing

• Experience working in a fill/finish manufacturing environment

• Experience in MES an advantage

• Experience of technical transfer of products

• Demonstrated problem solving abilities

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

Knowledge/Skills:

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

Relevant Experience:

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.

Shift Patterns and On-call Cover:

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 cover for weekends from 07:00 Saturday – 19:00 Sunday (excluding nights)