Manufacturing Operations Lead - Biotech - Dublin


Location: Ireland

EUR 25 - 35 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-2204-29416

Consultant: Karen McHugh






Are you a Manufacturing Operations Lead with 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry?

Ad hoc shift cover (24/7) may be required at an uplift rate of 35%

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353-1-7978720 to discuss in confidence.


Manufacturing Operations Lead - Biotech - Dublin


Job Description

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, 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.

Contractors have a history of either extending their contract or being offered permanent positions on this site.

The Operations Lead will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects. 

They will be 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 manufacturing facilities.

Function as the site interface between the Product Delivery Teams (PDT’s), and ADL 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)

3+ 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


Package

Contract role. €25- €35 Per Hour

Ad hoc shift cover (24/7) may be required at an uplift rate of 35%


Contact

Karen McHugh is the consultant managing this position.

If you are interested in this role you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.


JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Manufacturing Operations Lead roles in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.


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