Upstream Technical Specialist - Ireland
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Biologic Drug substance manufacturing operations team (Integrated Process Team) requires an Upstream Technical Specialist to provide Technical expertise to the Fermentation manufacturing team. This role will report to the Technology Lead, Biologic IPT.
- The Upstream Technical Specialist will demonstrate a high level of innovation, enthusiasm and drive to deliver technical excellence for characterization and optimization of bio manufacturing processes is accountable for the providing scientific and technical support to the fermentation operations team for effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers.
- This requires a flexible, collaborative, and coaching style and will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members.
- Provision of Technical Support of the large Scale Drug substance Manufacturing process including process performance monitoring, troubleshooting, process optimization.
- Provide Process Design Support during the construction and commissioning of unit operations in Fermentation facility and collaborating seamlessly with counter part in the Downstream area.
- Optimization of unit operations large scale to drive continuous improvement, process optimization in the Fermentation, processes.
- Lead and participation in cross-functional problem solving teams for troubleshooting, and investigations within API, Sterile and Quality in addition to other company Sites as required.
- Prepare analytical comparability plans in accordance with ICH Q5E to evaluate the comparability of pre- and post-change material.
- Preparation, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits. Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations
- Active pursuit of development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc
- Collaboration with internal and external partners
- Actively Participate in a culture of Continuous Improvement and process optimization by deploying company Six Sigma tools.
- Providing coaching and support to the Operations team to build their knowledge of process science.
- Demonstrated ability to fully realize improvement initiatives.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with the company Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
- MSc Degree in Microbiology (PhD Preferable).
- At least 2 years experience in similar Upstream/Downstream Technical Support role in Microbial or Cell culture and purification manufacturing would be an advantage
- Six Sigma Green Belt certified desirable.
- Evidence of Continuous Professional Development and Cross skilling
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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