Shire MS&T Bioprocess Engineer in Dunboyne, Ireland

**This is an Upstream & Downstream role**

The facility at Dunboyne will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. The role of Bioprocess Engineer will provide technical and engineering expertise to manufacturing operations and new product introduction at our new state of the art, single use multi-product biotech facility in County Meath, Ireland.

Key responsibilities of the Bioprocess Engineer across upstream and downstream biologics includes; the provision of technical expertise to ensure flawless launch and execution of new biologic-based medicines, the provision of technical leadership for product robustness in manufacturing, leadership of investigations and continuous process improvement at the Dunboyne facility.

This role will ensure all aspects of the Dunboyne culture including commitment to safety, right first time in everything we do and a focus on the engagement and development of employees. The role will provide coaching and mentoring to bioprocess engineers and technical professionals. It is a key position for seamless collaboration with manufacturing, quality and all functions across the value stream.

Responsibilities

SAFETY

  • Act as a role model for safety; you have a duty of care to yourself, your colleagues and the public to report any unsafe conditions and near misses at the time they occur.

  • Be knowledgable of emergency procedures in your area and across the site.

  • Perform safety audits, walkdowns and safety investigations.

  • Build safety as a value within every aspect of the operation that supports manufacturing and sustains Environmental Health and Safety (EHS) programmes at the site.

  • Ensure all manufacturing science and technology personnel adhere to safe working practices at all times.

  • To participate in process hazard and operability studies, conduct risk assessments and ensure appropriate safeguards are identified and associated actions are addressed.

  • Responsible for ensuring compliance with legal, EHS and all Shire policies and procedures which are applicable to the site.

PEOPLE

  • Ensure all team members are working as one team to support the delivery of product to patients.

  • Coach engineers and scientists within the team to build technical capability.

  • Be responsible for the engineering skills matrix to drive a learning and development organisation as well as maximising flexibility across the team.

  • Support the creation of a high performing organisation through implementation of a robust learning and development plan for the Manufacturing Science and Technology team.

  • Celebrate with use of proactive recognition tools that inspire teams and individuals

  • 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 create a culture of respect and dignity in line with the Shire Guide to ethical conduct.

  • Responsible for the goal setting, ongoing performance reviews and development planning within the Manufacturing Science and Technology Organization.

  • Represent Dunboyne Plant internally and externally to promote Shire Dunboyne and to support delivery of benchmark site performance.

OPERATIONS

Project-based Operations

  • Key member on the Manufacturing Science and Technology team interfacing with the project and technology transfer team to ensure the manufacturing facility will operate in accordance with user requirements and meet the key project milestones.

  • Define, coordinate and drive completion of upstream and downstream technical work packages with functional representation (cell culture, chromatography, UF/DF, filtration and drug substance bulk fill).

  • Provide technical input to meet Project timelines for design, facility start up, process validation and CMC product registration.

  • Represent Manufacturing Science and Technology for Technology Transfer activities and act as Receiving Unit subject matter expert / lead by coordinating activities across technical teams.

Standard Operations

  • Provide technical expertise and oversight within the manufacturing science and technology team, with a clear understanding of GMP and Safety expectations, to ensure the delivery of product to patients, in partnership with manufacturing.

  • Evaluate process flows and equipment trains for optimum performance, in line with lean principles and theory of constraints.

  • Identify innovation opportunities and lead activities for process optimisation, including yield improvement and cycle time reduction.

  • Coordinate change control activities to ensure proposed process improvements are planned and implemented effectively.

  • Evaluate new technologies that add value to site operations.

  • Develop and maintain expertise in manufacturing control systems to review day to day processing performance.

  • Develop and maintain expertise in process modelling to support technology transfer, process robustness, improvements and investigations.

  • Be recognized as subject matter expert for data analysis and management in order to build process knowledge.

  • Lead and drive CAPA investigations in accordance with the Shire Global Investigations Process.

  • Present investigation findings to regulators and demonstrate technical depth in defending the outcome.

  • Provide process training to manufacturing and value stream functions to support new product introduction and commercial manufacturing.

  • Lead new product introduction activities from an engineering perspective, including the preparation of basis documentation such as Process Flow Diagram (PFDs), batch records and risk assessments.

  • Provide technical ‘hands on’ leadership to new product introduction for flawless launch and execution.

  • Monitor new product introduction to ensure operational performance and schedule adherence is delivered.

  • Liaise with development teams for new product plant fits, gap analyses and cost of goods assessments for new processes on behalf of supply chain.

  • Lead and / or provide technical input to ensure the delivery of Business Excellence initiatives.

  • Demonstrate proficiency in the use of Operational Excellence tools and techniques.

  • Participate in companywide teams, programs and external networks to develop technical capability within the organization.

  • Provide process expertise to the manufacturing and engineering teams for delivery of projects from concept to implementation phases.

  • Act as owner for validation activities to support new product introduction and commercial manufacturing.

  • Develop and maintain project and program management capability within manufacturing science and technology.

  • Play a key role in delivering the startup plan for the site, acting as an area SME during the handover process from commissioning through into qualification and process validation.

Education and Experience Requirements

  • Professional- Bachelor of Engineering Degree / equivalent, min. 2-3 years’ of experience

  • Master of Engineering degree / equivalent with min. 2 years of experience.

  • Ph.D. with min. 1 year of experience (scientific discipline in biotechnology, biochemistry, pharmacy, process engineering or equivalent).

  • Senior Professional- Bachelor of Engineering Degree / equivalent, min. of 3-5 years’ experience.

  • Technical expertise with Biologics drug substance upstream and downstream purification, process development and/or manufacturing operations.

  • Experience of team membership or lead of process technology transfers for clinical/commercial biologics.

  • Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.

  • Experience of bioprocess facility design and start-up is desirable.

  • Experience in leading investigations is desirable.

  • Accredited Lean/six sigma/DMAIC competency is desirable.

  • Accredited Project Management competency is desirable.

Key Skills, Abilities, and Competencies

  • Effective communicator with deep engineering / scientific expertise.

  • Understanding of Quality by Design (QbD) and Good Manufacturing Practices (GMP) to enable right first time Process Performance Qualification (PPQ).

  • Excellent knowledge of statistics and DOE principles to drive continuous process verification in manufacturing and across the network.

  • Proven ability to contribute towards process changes and to support new product introduction, applying knowledge of risk assessment tools and the Quality system.

  • Technical leadership skills to explain and simplify complex information for others in support of business decisions.

  • Proven skill to develop practical options in support of decision making.

  • Ability to lead others to solve problems and take new perspectives on existing solutions

  • A proven ability to lead a team and promote a culture where diversity and inclusion is supported.

  • Strong coaching skills to build technical capabilities in the team.

  • Excellent trouble shooting and problem-solving skills.

  • Excellent influencing, collaboration skills and teamworking ability to represent manufacturing science and technology on global and interdisciplinary teams.

  • Stakeholder management skills to collaborate across site and global teams.

  • Ability to challenge the status quo with a continuous improvement mindset.

  • Proven ability in the use of lean tools and in building capability across teams to set clear standards in how work is done.

Complexity and Problem Solving

  • Identifying and communicating risks in delivery of the manufacturing schedule.

  • Communicating decisions and risks related to the technology transfer of new products

  • Acts as an advisor / lead for the resolution of technical investigations, presenting options to leadership for endorsement of decision, as appropriate.

  • Exercises judgment when recommending a course of action to support manufacturing operations, including clear communication and alignment with the manufacturing team.

  • Makes a balanced assessment of risk for process optimization projects, with the right stakeholders informed of the approach taken.

  • Develops Process and Cleaning Validation criteria to ensure product quality requirements are met, leveraging development studies and the established design space.

  • Evaluates the input and output from self-directed teams in manufacturing, providing requisite technical resources to support the schedule and / or optimization projects.

Internal and External Contacts

  • Collaborate with other site MS&T Functional Groups (Product Lifecycle, CMC, QbD/Validation, Process & Analytical Development).

  • Collaborate with Product teams (TOPT/CMC) to ensure Product Lifecycle/ process changes improvements are fully assessed, endorsed and implemented to sustain patient supply.

  • Collaborate with Manufacturing Operations on process and cleaning validation, performance trend monitoring, investigations and in the delivery of improvement opportunities.

  • Collaborate with Quality and EHS with regard to investigations and change controls impacting on manufacturing. Collaborate with Quality to foster a right first-time culture in support of quality excellence.

  • Collaborates with EHS and is accountable to drive a culture of everyone owns safety.

  • Collaborates with Engineering for all change controls, investigations, continuous improvement and projects related to the process equipment operating parameters. Providing requisite technical specifications, as appropriate.

  • For Automation , establish process requirements to allow optimal operating parameters to be defined for manufacturing operations and in making process improvements.

  • Partner with Supply Chain to ensure effective product lifecycle management. Provide input to ensure long term capacity assessments and product / plant fits are completed in line with master planning.

  • For continuous improvement, collaboration with Business Excellence and peers across the Biologics business unit in Shire and through external forums to drive business excellence in processes/ manufacturing.

  • Collaborates with Regulatory Affairs to ensure process changes are in compliance, while supporting submission generation and response requests from health agencies.

  • Collaborates with CRO/CMO labs to design and execute development studies.

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.