Manufacturing Bio-Process EngineerApply Now Email Me Job ID SR0032977 Date posted 02/06/2019 Location:Dunboyne, Ireland
The Manufacturing Process Engineer will play a key 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 Takeda Biologics. The organizational 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
1. Safety Responsibilities:
- Build safety as a value within every aspect of the value stream supporting manufacturing operations that ensure sustainable EHS programs that are engrained and deployed into each area.
- Responsible for adhering to and ensuring compliance with legal, EHS and all Takeda 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.
2. Responsibilities towards People:
- Work closely with members of the Manufacturing organization to help support the value stream and self-directed teams.
- Support the creation of a high performing site organization by providing feedback to other members of the manufacturing organization, 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 Takeda behaviors
- Role model the behaviors that creates a culture of respect and dignity in line with Takeda Guide to ethical conduct
3. Functional Responsibilities:
- 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 behaviors, 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.
- Partake in 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 optimizations 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 & EXPERIENCE REQUIREMENTS
- Bachelor’s degree in a technical discipline (Science or Engineering)
- gained first experience working in a BioPharma environment
- Proven ability around working cross functionally, delivering technical solutions and identifying improvements.
- Experience working in a self-managed work team, embracing an interdependent working culture that delivers results.
KEY SKILLS, ABILITIES & COMPETENCIES
- Living the Takeda behaviors of Fairness, Honesty, Integrity and Perseverance
- Ability to translate the vision and goals of the company and site to the Self-directed teams.
- Enterprise mindset to ensure the right prioritizations take place
- Strong project management skills.
- Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
- A proven ability to get involved in cross functional teams and deliver on tight timelines.
- Excellent influencing/collaboration skills and teamwork mindset.
- Excellent trouble shooting and problem-solving skills
- Ability to challenge the status quo with a continuous improvement mindset.
- Change agent who will support the organization with good change management tools and techniques.
- Effective communications skills
- Promoting a culture where diversity and inclusion is part of the DNA of the site
INTERNAL & 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 MS&T 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 Takeda 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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.