Job Description
Our client, a Biotech company based in Munster region, now has approval for a MES Principal Specialist who will work as part of the Manufacturing Process Development group in their new build Biotech manufacturing facility. This is an exciting opportunity to help build and operate a state-of-the-art greenfield Biotech manufacturing site.
The successful candidate will be a subject matter expert in Manufacturing Execution Systems (MES), with responsibility for driving the MES requirements to meet the process and manufacturing needs across all unit operations. As MES expert, this hire will lead interactions with IT and business reps on MES design and problem resolution.
Additionally, this hire will identify improvements required in order to deliver a final MES product which complies with regulatory requirements. This role will help deliver advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
This hire will have ability and expertise to work in collaboration with manufacturing process development team and cross-functional colleagues onsite, and network with colleagues on sister sites in Ireland and US.
Responsibilities:
Work with different production areas to ensure adequate resourcing for MES development, design and delivery in manufacturing development.
Develop understanding of MES across all areas of the business.
Identifying and implementing further business integration for MES.
Work with technical groups on production areas to ensure optimum MES design for production processes.
Work with business team leader and MES leader to ensure MES team is adequately supported by production areas.
Identify training gaps and work with business team leader to develop MES business support structures.
Identify new business processes required and work with business MES reps to design the process.
This role will help deliver advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
Requirements:
Bachelors Degree in Science or Engineering.
3+ years' experience specifically in a manufacturing execution systems (MES) role in pharmaceutical environment, to required regulations (cGMP, HPRA and FDA).
People leadership skills to guide IT and business reps on problem resolution and MES design.
Proven experience of cell culture and/or purification techniques used in the manufacturing of biotech products.
Strong interpersonal and communication skills with a willingness to lead others through processes.
Strong analytical and problem-solving skills.
For further details, please contact Larry on +353 (0) 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter