Facilities & Utilities Engineering Lead – Takeda Bray
The Facility/ Utility Engineering Lead is responsible for the organization and leadership of the site Facility/ Utility Engineering team. Responsible (Owner) for technical availability, operation, optimization, maintenance and lifecycle management of site facility/ utility systems, including oversight of the IFM provider
Optional hybrid work model.
How you will contribute:
- Leads, develops, and trains high performing Facilities/ Utilities team
- Responsible for operation and maintenance of site Facility/ Utility systems
- Provide management oversight of the IFM provider on the site
- Lead Root Cause Analysis of major equipment failures and drive the implementation of corrective and preventive actions
- Budget for own area of responsibility
- Maintain high level of compliance with local and global safety and quality standards
- Processing of deviations and CAPAs in the area of responsibility
- Represents the site as a member of the global carbon community of practice (CAPS) through sharing of best practices and lessons learned
- Support Takeda’s Global Sustainability Program objectives through monitoring and management of carbon/energy/water/waste for the plant
- Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors
- Ensure that new or modified equipment are designed for Reliability, Maintainability and Accessibility by providing design requirements to the Project Team and participate in reviews and risk assessments during the design process
- Increase equipment uptime, eliminate waste, and prolong asset life by developing optimized maintenance strategies that detect, prevent, or predict failures
- Develop the Preventive Maintenance (PM) plans, frequencies/intervals, and spare parts lists and maintenance bill of materials
- Lead the program at the site to evaluate the lifecycle and health of Facility/ Utility equipment and forecast the remaining life and plan when aging equipment need to be disposed of and replaced
- Consultant and representative for Facility / Utility systems in all investment projects on site
- Supervise contractors and outside vendors
- Other duties as required and directed by the Head, Site Engineering or other Officer appointed by the Board of Directors
Technical/Functional (Line) Expertise
Experience in Facility/ Utility systems relevant to an oral solid dose pharmaceutical manufacturing plant
Leadership experience
Understanding of cGxP regulations
Leadership
Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems
Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/prioritization
Decision-making and Autonomy
Must demonstrate effectiveness in decision-making, empowerment of others, exception management, training, problem solving and team management
Interaction
CAPEX Project Teams, Plant/Process Engineering, Maintenance, Calibration, Spare Parts Manager, EHS, Quality, Manufacturing/Production, Equipment Vendors, Automation
Actively embrace the culture of teamwork and integration within the Engineering Department, and most importantly with both Manufacturing/Production and Quality Departments
What you bring to Takeda:
- Bachelors' degree in an Engineering discipline required. 7+ years of related experience with 3+ years in a leadership role
- A strong leader capable of mentoring, motivating and leading a team of Engineers/ Technicians
- Good communication skills, analytical skills, ability to work on his/her own on solutions including planning and organization, innovative networked thinking, experience in project and preferably program management
- Understanding of Good Manufacturing Practices (GMP). Prior experience interacting with the FDA and other regulatory agencies preferred
- Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable
- Must be a natural team player, able to develop strong working relationships with the rest of the management team.
- Ability to plan workloads & work to tight timelines.
Maintenance Lead – Takeda Bray
The Maintenance Lead is responsible for the supervision, development, and training of a team of multi-skilled technicians. Work in close collaboration with the Maintenance Planner to ensure planned and unplanned maintenance is completed safely, to GMP standards, and in a timely manner
Optional hybrid work model.
How you will contribute:
- Supervising technicians and assessing their performance
- Perform routine and non-routine maintenance, repairs, and troubleshooting of process and packaging equipment
- Plan and Schedule the routine and Non-routine maintenance work and coordinate the work with customers and communicate when work is completed
- Support and drive improvement of the EHS metrics for the department
- Ownership for CAs & PAs relevant to the maintenance team
- Develop and maintain Key Process Indicators for the team
- Encourage, promote and lead the use of LEAN / Six Sigma tools
- Development of a training program for the team of multi-skilled technicians, integrated into TIL Brays Training platform
- Maintain equipment data in the Computerized Maintenance Management System (CMMS)
- Manage and oversee contractors and vendors who perform maintenance activities and review their reports and records
- Apply safety measures such as Lock-Out-Tag-Out of systems, and Personal Protective Equipment (PPE) to ensure maintenance work can be performed safely
- Support internal and external Audits and Inspections of the Maintenance Program
- Promote a positive environment within the maintenance team, ensuring that there is regular and open dialogue with responses to promote Takeda as a Good Place to Work
- Technical/Functional (Line) Expertise
- Experience in process and packaging systems relevant to an oral solid dose pharmaceutical manufacturing plant
- Understanding of cGxP regulations
Leadership
- Leadership experience with teams of multi-skilled technicians
- Decision-making and Autonomy
- Must demonstrate effectiveness in decision-making, empowerment of others, exception management, training, problem solving and team management
Interaction
CAPEX Project Teams, Plant/Process Engineering, Calibration, Spare Parts Manager, EHS, Quality, Manufacturing/Production, Equipment Vendors, Automation
Complexity
Must have advance experience and proficiency in problem analysis and resolution, successful track record of analysing complex technical problems, and demonstrates good troubleshooting and decision-making abilities
What you bring to Takeda:
- A recognized and applicable third level engineering qualification. At least 7 years of relative maintenance and technical experience and 3 years of people management experience, preferably in the pharmaceutical industry
- A strong leader capable of mentoring, motivating and leading a team of Engineers/ Technicians
- Understanding of Good Manufacturing Practices (GMP). Prior experience interacting with the FDA and other regulatory agencies preferred
- Supervisory/management skills (performance reviews, talent management, vacation planning, etc)
- Lead by example to establish a culture of safety, quality, respect, accountability, and reliability
- Ability to communicate and deal with personnel at all levels within the organisation
- Knowledge of safety standards, hazards and appropriate precautions applicable to maintenance work
- Technical writing ability including supporting documentation for change controls and investigations
Maintenance Technician – Takeda Bray
This brief demands flexibility and cross-functional liaison and co-operation, combined with competent technical ability. In addition, the Engineering Technician is required to assist in the safe and efficient operation of maintenance systems in compliance with regulatory, cGMP and to HPRA and FDA standards.
Key Responsibilities
- Work with flexibility within the Engineering Department and in co-operation with other Departments.
- Promote lean maintenance best practices at all times within a continuous improvement environment.
- Assist in developing and improving new and existing maintenance routines within a cGMP environment.
- Carry out planned/unplanned maintenance on packaging, production and utilities equipment.
- Proactively follow up on re-occurring technical issues.
- Use of the computerized maintenance management system to record in detail maintenance activities on equipment/utilities in compliance with regulatory & cGMP requirements.
- Execution of work orders as scheduled through the computerized maintenance management system SAP.
- Completion of non-trade specific work as required.
- Daily reporting of maintenance activities at shift meetings, ensuring issues and open items / concerns are communicated in a timely and concise manner.
- Participate in Safety and Environmental training programmes and initiatives. Adhere to safe working practices as set out by the Safety Statement and other company safety rules.
- Maintaining compliance with site procedures and policies.
- Participate fully in any cross-functional training initiatives and mentor operations personnel at all times.
- Available to respond to ‘call out’ as per a pre-defined rota if required.
- Develop and maintain a strong working relationship with all the departments’ customers on site.
General Responsibilities
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the Manager, Maintenance or other Officer appointed by the Board of Directors.
Educational Requirements
A suitable qualification in an electrical, instrumentation or mechanical engineering discipline.
Minimum of an electrical or mechanical apprenticeship with a minimum of 2 years experience and or an electrical or mechanical engineering degree.
Key Experience
- A minimum of 2-3 years experience in the pharmaceutical industry post qualification is essential.
- Experience in the area of Packaging is advantageous
Skills/Competencies
- Proven track record of high performance & delivering results.
- The determination and drive to sustain current best practices and the ability to identify develop and implement future best practices
- Interest in continuous improvement.
- Good interpersonal skills.
- Ability to work well independently and as part of a team
- Customer service and task focused.
- Good computer skills and CMMS experience (Word, Excel, CMMS software)
Senior Maintenance Manager – Takeda Bray
The Senior Maintenance Manager is responsible for strategic leadership, coordination and alignment of the Maintenance team based on the business needs. In this role, he / she is recognized within Takeda as subject matter expert (SME) and is responsible for the safe and efficient maintenance of process, facilities and utilities assets in a pharmaceutical plant operating to HPRA and FDA standards.
This position reports into the Head of Site Engineering at the manufacturing site. The Senior Maintenance Manager is an integral member of the Site Engineering Leadership Team. He / she also interacts closely with the Managers within the Operational Leadership Team at the facility to ensure they are supported at all times. This role is seen as successor for Site Head of Engineering.
Optional hybrid work model.
How you will contribute:
Ensures that the Maintenance team is staffed with the appropriate skills and capabilities to meet all Site Engineering functional goals
Establishes an efficient Maintenance organization focusing on right first-time delivery and following industry best practices to meet the strategic needs of the plant
Develop a vision and implement a lean maintenance strategy for the department, maximising the use of digital tools and technologies, accelerating the move to a smart factory
Ensure that Manufacturing Operations is supported at all times. Establish availability and reliability measures for key pieces of process equipment.
Ensure an effective training program is developed, maintained and executed for both technicians and engineers within the maintenance department.
Take a lead role on the site energy management team, focusing on Takeda’s global target to be carbon neutral by 2040
Maintain budgetary control of maintenance operational budgets, working closely with Finance.
Act as primary contact for the site’s insurance providers. Ensure compliance with insurers requirements.
Participate in safety programmes. Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
Encourage actively the culture of teamwork and integration within Engineering, and most importantly with Manufacturing Operations, Quality, EHS & HR departments.
Foster talent within the department, create development goals for department members, and have succession plans in place
Take measures to ensure that a good work / life balance is achieved for department members, and continuously strive to make Takeda Bray a highly desirable place to work
Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
Other duties as required and directed by the Head, Site Engineering or other Officer appointed by the Board of Directors.
What you bring to Takeda:
- Technical/Functional (Line) Expertise
- Experience in Maintenance at GMP Pharmaceutical manufacturing plant
- Leadership experience
- Leadership
- Influencing and collaboration skills.
- Leadership and problem solving skills.
Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- A strong leader capable of providing leadership to teams of Engineers and Technicians
- Bachelors' degree in Engineering discipline required. 15+ years of related experience with minimum 7+ years in a leadership role
- Experience in pharmaceutical GMP manufacturing processes, control systems, process equipment, facilities/utilities, and critical support systems
- Thorough knowledge of Maintenance execution strategies and best practices
- Strong interpersonal skills and communication abilities. Able to manage up and across the organization
- Business acumen
Takeda Bray – Process Support Engineer
Takeda Bray has a fast paced work environment and we seek talented employees who crave learning new skills and aren't afraid to tackle big projects. As an employee you will get to work with a variety of our staff, while working on projects that will help the company grow.Our ideal candidate is someone who has excellent organisational, communication and time management skills. Someone who has an interest in developing their skills, works well in a team and is eager to learn new skills and techniques.
Our Engineering Department is based in Bray and we look after the management and implementation of Site Projects and Process Support function of process equipment and facilities. You will have the opportunity to grow and learn alongside industry professionals from multiple engineering disciplines. We work in a high performance environment where collective and collaborative achievement is the cornerstone of how we work as a team.
Candidates are invited to apply for the position of Process Support Engineer at Takeda Bray. This is a great opportunity for a recent graduate or junior engineer to gain exposure to a wide range of Pharmaceutical Processes and Project management techniques within a Pharmaceutical manufacturing site. We offer a flexible and supportive work environment and are willing to assist in developing your skills and abilities to further your career opportunities.
JOB PURPOSE:
The Process Support Engineer is responsible for providing technical support to both Engineering and Manufacturing Operations departments to ensure the safe and efficient operation of process equipment in a pharmaceutical plant operating to HPRA and FDA standards.
RESPONSIBILITIES:
- Support and lead key areas of process improvement projects to improve equipment availability and production efficiency – “continuous improvement programme”.
- Assist with project work connected with installation, validation, and commissioning of new and existing process equipment and automation control systems.
- Assist with monitoring and control of process equipment and general facilities with regard to maintaining a constant, safe and reliable operation.
- Work with the Production Department to provide adequate support during process investigations and CAPA implementation.
- Maintain effective document control systems for the Process Support Group.
- Actively embrace the culture of teamwork and integration within the Engineering Department, and most importantly with both Production and QA Departments.
- Participate fully in any cross functional Training initiatives, Drive and promote the corporate values of Takeda-ism within the workplace
- Adhere to safe working practices as set out in the Safety Statement and other safety instructions.
- Adhere to the company cGMP procedures at all times
GENERAL RESPONSIBILITIES:
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
EDUCATIONAL REQUIREMENTS:
- A recognized third level engineering degree is desirable.
- Knowledge of Tablet Compression, Granulation, Packaging and Serialization equipment would be beneficial
- Minimum of 2-3 years’ experience but recent graduates will be considered
SKILLS/COMPETENCIES:
Be a self-starter who is motivated and willing to learn.
Excellent interpersonal, communication, presentation, report writing and time management skills.