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Shire Manufacturing Senior Bio-Process Engineer in Dunboyne, Ireland
The Senior Bio- Process Engineer will play a critical technical role in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
Key responsibilities of the role will include the use of process engineering systems and approaches for equipment design, specification and performance, generation of technical reports, process modelling, risk management and integration of process equipment systems. Ongoing optimization of process equipment and development of future breakthrough business solutions will be key focus areas. The role will involve working as part of a team of bio-process engineers who will be responsible for ownership and management of change of the electronic batch records, identifying equipment, recipe and process improvements and managing and controlling changes in these areas. The Senior Bio-process engineer will lead significant projects and will play a key role in the coaching and development of the Manufacturing technical team.
Build safety as a value within every aspect of the value stream supporting manufacturing operations that ensure sustainable EHS programmes that are engrained and deployed into each area.
Responsible for adhering to and ensuring compliance with legal, EHS and all Shire policies and procedures which are applicable to the processing engineering and technical support activities on site.
Create an environment where everyone speaks up for safety and looks out for one another.
Coach and mentor other members of the Manufacturing Technical team to help support the value stream and self-directed teams.
Support the creation of a high performing site organisation by providing feedback and coaching to other members of the manufacturing organisation, combining experience and technical knowledge to help the site strive for technical solutions that fit the operations being undertaken by the plant based teams.
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.
Be an ambassador for the Shire leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
Role model the behaviours that creates a culture of respect and dignity in line with Shire Guide to ethical conduct.
Use a focused, technical, problem solving approach to meet and exceed on functional and site goals and objectives.
Act as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, conducting and leading investigations.
Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance.
Play a key role in developing process engineering related documents, technical SOPs, reviewing automation related functional design specifications and generating technical reports.
Be an owner of specific EBRs in the facility, making technical changes are required to meet the demands of the business or in response to any requirements for process changes that may occur. Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility.
Own the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.
As a senior bioprocess engineer within the team take the lead on specific manufacturing projects that arise on the process, equipment or systems providing a structured lean approach to problem resolution.
Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on removing barriers to maintain a highly effective and productive self-directed team environment.
As a key member of the start-up team on site play a key role in the commissioning and qualification activities on site, acting as a lead end user for systems as they transition across to the operations teams. Ensure consistency between recipe design and technical SOPs.
Stay abreast of industry innovations, looking at ongoing optimisations of the single use technology being employed on site.
Act as a key SME for the introduction of new process equipment into the facility, and provide technical training or support for the operations based manufacturing personnel as equipment is brought on line.
Education and Experience Requirements
Bachelor’s degree in a technical discipline (Science or Engineering).
At least 5 years’ experience in the biotechnology and/or pharmaceutical industry, with experience in automated systems a distinct advantage (PAS systems, MES systems).
Experience leading significant process or plant improvement projects.
Proven ability around working cross functionally, delivering technical solutions to manufacturing issues and identifying solutions.
Experience working in a self-managed work team, embracing an interdependent working culture that delivers results.
Strong operations support background ensuring value added contribution and oversight.
Experience working in a GMP manufacturing environment.
Key Skills, Abilities, and Competencies
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following: Leadership Behaviors
Be Results Oriented
Be an Excellent Manager of Self and Others
Ability to translate the vision and goals of the company and site to the Self-directed teams.
Enterprise mindset to ensure the right prioritisation for the site.
Strong project management skills to support project delivery and operational readiness.
Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
A proven ability to lead cross functional teams and deliver on tight timelines.
Excellent influencing/collaboration skills and teamwork mindset.
Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving.
Ability to challenge the status quo with a continuous improvement mindset.
Proven ability in using a wide variety of lean tools and building capability within teams.
Change agent who will support the organisation with good change management tools and techniques.
Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching.
Effective communicator with a proven ability to grow talent and future leaders.
Promoting a culture where diversity and inclusion is part of the DNA.
Complexity and Problem Solving
Delivers upon challenging assignments and looks for stretch goals for self on an ongoing basis.
Comfortable providing coaching and guidance to team members on technical issues to achieve goals in accordance with established polices and business needs.
Identifying and communicating risks and concerns in area of responsibility and across the site.
Internal and External Contacts
Collaborate with Quality and EHS regarding investigations and changes controls impacting on process engineering and manufacturing operations activities. Collaborate with Quality to foster a right first-time culture in manufacturing to support quality excellence.
Collaborates with EHS but is accountable to drive a culture of everyone owns safety in manufacturing.
Collaborates with Supply Chain on bill of materials issues and technical concerns relating to materials.
Collaborates with Plant and Project Engineering groups on equipment issues and plant modifications.
Works closely with the Automation team on site to ensure that process recipes are fit for purpose and aligned with the technical procedures operating within manufacturing.
Collaborates with PDST on new product introductions to ensure that the plant is set up to deliver on new process introductions or process changes.
Collaborates with all manufacturing members to deliver the site objectives.
For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Shire and through external forums to drive business excellence in manufacturing.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.