Operations Lead

Orion Group are sourcing a Operations Lead on behalf of our Multinational Biotechnology Client on an initial 12-month contract located in South Dublin with huge potential to extend.

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 facilities.

Primary responsibilities:

* Function as the site interface between the Product Delivery Teams (PDT's), 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

Knowledge/Skills:

* 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

* 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.

* 2+ 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.

For more information on this role, call Beatriz Olmedo on +353 21 235 2900 or email beatriz.olmedo@orioneng.com for a completely confidential chat about this role and other opportunities.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.