PE Global is currently recruiting for a Manufacturing Operations Role for a leading multi-national Biotech client based in Dun Laoghaire.
This is an initial 12-month contract position.
ROLE:
- Function as the site interface between the Product Delivery Teams and Manufacturing operations.
- Develop, review and approve generic 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 process/project
- Evaluate, plan, and implement solutions for process improvement opportunities
- Support scheduling and execution of Characterisation, Engineering and PPQ runs including 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 behaviours within Product team
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
- Partner with Learning & Performance to define training strategy’s for NPI’s and complex projects
- Liaise 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
- Liaise with Process Development regarding process changes in an effective and timely manner
- Own and lead change controls as required by the NPI Project Team
- Review and approve bills of materials
- Develop, review and update Product Quality Risk Assessments
- Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits
REQUIREMENTS:
- Bachelor’s degree in a science discipline.
- Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
- 2+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
- Project Management and organizational skills, including ability to follow assignments through to completion
- Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
- Negotiation and Influence 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
- Ensures compliance within regulatory environment
- Demonstrated ability to work independently and deliver right first-time results under minimal direction
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Apply on Linkedin
