Job Description
My client a leading and rapidly expanding Pharmaceutical Company now require a Manufacturing Site Shift Lead to join their rapidly expanding team.
The Manufacturing Site Shift Lead will lead all manufacturing operations as well as support activities on their designated shift for our new state of the art single use multi-product biotech This role will ensure that all aspects of the site culture including commitment to safety, right first time in everything we do and a focus on the engagement and development of employees is prioritised. This role is a critical role on the manufacturing leadership team as well as the most senior person on shift at the site.
This is a permanent role based in North Dublin.
Responsibilities of Manufacturing Site Shift Lead
- Lead the site shift operations ensuring that all manufacturing operations are completed to schedule. This includes completion of batch record review, investigations and the completion of all scheduled activities including sampling, cleaning, preventative maintenance, calibration, changeovers, validations and projects.
- Provide timely visibility through tier meetings and visual management on progress against value stream KPIs, delays, action plans, improvement opportunities and recognition.
- In partnership with the manufacturing leadership team create and sustain a culture of excellence in safety, quality and continuous improvement.
- Create an environment of right first time in everything that we do through a focus on principles of lean including simplification, standard work, visual management and a learning organisation as part of the tier meeting structure and ensure shift automation and process engineering are engaged in making changes/ improvements that support right first time improvement and error proofing.
- Be accountable for a robust investigation process to drive to right first time. • Ensure objectives are aligned, integrated across the shift team, translated to all and visually managed to drive delivery.
- Deliver on the annual business plan including all KPIs related to safety, quality, people and productivity in partnership with the site manufacturing leadership team and the value stream leadership team.
- Represent Plant internally and externally to promote my client as a great place to work and to support delivery of benchmark site performance.
- Responsible for ensuring compliance to all requirements of current Good Manufacturing Practice.
- Strengthening overall leadership and organizational capabilities in area of responsibility.
- Be ready and capable of leading on discussions with auditors on plant based activities and in leading on audit walk downs.
- Play a key role in delivering the start-up plan for the site, acting as an area SME during the handover process from commissioning through into qualification and process validation.
- Ensure that all employees on shift supporting manufacturing are working as one team to support the delivery of product to patients.
- Be responsible for the shift skills matrix to drive a learning and development organisation as well as maximizing flexibility across the shift team.
- Coach and mentor all employees on shift including all indirect employees supporting the value stream.
- Support the creation of a high performing site organisation through implementation of a robust learning and development plan for the shift team, providing feedback to all employees on shift and the implementation of a robust communication plan to the shift including 1:1s, skip levels, development planning, and regular site updates.
- Celebrate with use of proactive recognition tools that inspire teams and individuals.
- Create an environment where everyone speaks up for safety and looks out for one another.
- Role model the behaviours that creates a culture of respect and dignity in line with company guide to ethical conduct.
- Responsible for the goal setting, ongoing performance reviews and development planning of each employee on shift.
- A level 8 Bachelor of Science or Engineering degree or equivalent.
- A minimum of 8+ years’ experience in Bio-Pharmaceutical Manufacturing / Engineering with 3+ years’ experience required in a leadership role with a multi-national organisation. This experience must include biologics drug substance, with start-up experience being a distinct advantage.
- Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
- Experience working in an automated facility would be a distinct advantage
The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below