Title: Process Owner
Location: Dun Laoghaire
The process owner role will be led by individuals who have an in-depth technical knowledge of the processes to manufacture biologics at the site. The expertise that these individuals have will be essential to support key areas of the business. This is through investigations and directing initiatives that impact on the Manufacturing processes. The key areas of the fill/finish Manufacturing areas that require this support are Syringe Filling, Vial Filling, Formulation, Part Preparation, Lyophilisation and Capping.
* Supporting new technology initiatives in the manufacturing suites by serving as the single point of contact and technical knowledge for the process that you have been assigned.
* Owning the process that you have been assigned. This will include an in-depth knowledge of the process, making sure that procedures and batch records are clear and correctly direct the process.
* Providing your expertise to make sure that NPIs/Projects that are to be implemented in the manufacturing area are completed successfully.
* Develop, review and update Production, Engineering, Operating Procedures & training materials
* Engaging with staff members within the manufacturing area to ensure technical understanding of the processes that you are assigned.
* Supporting investigations that impact on safety or product quality from a technical standpoint on the process ensuring thorough investigations are carried out.
* Ownership of safety and quality related CAPAs to make sure that the right measures are identified and implemented to prevent future reoccurrence.
* Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the area that they are responsible for.
* Provide technical input to the shifts on challenges that are encountered. Actively looking at ways to assist in the running of the business and provide support to actions that are related to their process.
* Effectively engaging and participating within a Lean culture environment where continuous improvement behaviours are expected, and programs are employed. The role will require incorporation of Lean concepts into assigned project(s). Managing and implementing projects that develop lean practices in the manufacturing areas.
* Providing input to strategic initiatives that will improve and develop Manufacturing for the future. The Process Owner will then support any projects identified and will be a project manager on some initiatives. They will make sure that project timelines are met, challenges identified, and mitigation's are in place and provide high level of communication and visibility on any projects that they own.
* Monitor any process trends, including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future.
* 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 using lean six sigma tools
* 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 and ensures aseptic compliance throughout every project
* Demonstrated ability to work independently and deliver right first-time results under minimal direction
* Familiar with data analytics
Qualifications and Experience:
* Bachelor's degree in a science or engineering discipline.
* 5+ 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.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.