Manufacturing Shift Lead

Job Description

A fantastic and exciting opportunity has arisen for a Manufacturing Shift Lead at Dunboyne Biologics.

This role will be part of the Manufacturing Self Directed work team/hub in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. 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.

The Shift Lead will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to achieve our Governance Pillars in People, Safety, Quality, Delivery, and Cost.

The Shift Lead will lead a team of biotech associates in the production of biologic drug substance who are responsible for the day to day shift operations at the site. This role will ensure that all aspects of the Dunboyne culture including commitment to Safety First Quality Always, right first time in everything we do and a focus on the engagement and development of employees is prioritized. Reporting to the Manufacturing Operations Lead, this role is a central role on the manufacturing self-directed work team.

What you will do:

Bring your energy, knowledge, and innovation to:

• Build safety as a value within every aspect of the value stream supporting operations.
• Partner with the EHS Hub to ensure sustainable EHS programmes are engrained and deployed to develop effective integrated solutions to EHS requirements, to develop a valuable EHS learning programme for people and to manage safety initiatives.
• See safety as an investment by committing the necessary resources (people, equipment, time) to strengthen safety performance.
• Ensure that all operations are performed in conformance with site safety, environmental and quality procedures thereby ensuring department is audit/inspection ready.
• Effectively deploys resources to maximise productivity.
• Manage production related schedule adherence, tasks and resources on shift team and cross functionally.
• Develop plans to meet short term business objectives or leads projects in line with business goals.
• Manage vacation for direct reports to ensure department budgets are met while adhering to schedule targets.
• Responsible for ongoing training and development of team members as well as tracking and closure of gaps.
• Drive effective writing/revising/rolling out of accurate operational procedures, training materials and standardized work for various Production systems.
• Ensure all work is completed in line with procedural requirements and real time documentation completion.
• Get actively involved by participating in inspections, GEMBA’s and Go-See’s.
• Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture and actively coach the team to do the same, promoting the conversations that support their active participation.
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
• Recognise contributions and safety achievements using the proactive recognition tools that inspire teams and individuals. Take the time to find out about the effort people are putting in to improve safety, and meaningfully celebrate them.
• Create a team environment that keeps safety at the front of mind of the team driving continuous improvement.
• Work as a member of the site emergency response team. Can act as designee site Incident Commander in the event of an accident or incident on site.
• Engage proactively with teams through active 1:1s, skip levels, development planning, and regular site updates that fosters a continuous learning and growth environment.
• Continually assess and develop the performance of each member of the shift team and provide timely feedback to members of the team on their performance and application of consequences (both positive and constructive) where required.
• Manage performance in line with direct report AIP requirements.
• Drive an environment that ensures the team have clear workplans and development plans that enables each employee to achieve their full potential through coaching and mentoring.
• Align the team and individual goals to provide a direct line of sight for each employee to the team and Dunboyne objectives.
• Role model the behaviours that creates a culture of respect and dignity in line with our company’s Guide to ethical conduct.
• Have an active role in the shift handover process, working to ensure that transitions occur as smoothly as possible and that the production activities are closely monitored and controlled always
• Support the development and continuous update of the value stream map.
• Support development and regular update of the site capacity evaluations to identify projects and initiatives that support site ramp up and sustainability.
• Utilize continuous improvement tools, lean and six sigma methodology to identify improvement opportunities, perform technical troubleshooting and successfully implement solutions.
• Support the implementation of site strategy and business unit strategy by identifying appropriate initiatives for applicable improvements to the value stream. In some instances support and encourage new and innovative corporate initiatives and projects.
• Identify the appropriate business drivers for each initiative, draft proposals and seek appropriate governance approvals.
• Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• Support detailed project planning including but not limited to schedule and resources and successfully execute cross functional projects.
• Prepare timely project reports and communicate effectively with all stakeholders including reporting any potential project delays timely and provide mitigation plans to assure on-time execution.
• Work with the Enterprise Schedule team to ensure the Lean learning strategy is incorporated and the capability build is visible to support business needs.
• Report on Value Stream Key Performance Indicators & Metrics.
• Complete time/attendance approval and ensure payroll accuracy.
• Support the implementation of the Lean Management System.
• Manage Budget Control ensuring a return on Capital Invested and drive a cost consciousness in the team to understand spend and treating and managing cost as if they owned it.
• Undertake job specific activities
• Drive the production process forward through use of Delta V recipes & Electronic Batch records according to relevant SOPs
• Take ownership for one’s own training to continue professional development and generate expertise in the role
• Play a key role in the roll out and development of standard work processes on the plant, continually looking for improvements and operational efficiencies
• Role model safety behaviours as a standard for others to follow adhering to all safety requirements for tasks required.
• Take an active role in shift handovers and tier 1 meetings following the Commit behaviour of getting involved, raising concerns or issues promptly and providing options for resolutions
• Act as a team member on process deviation reviews and Gemba walkdowns
• Act as end user where required for manufacturing input into automation, equipment and process changes to ensure that the operational aspects of any change are well understand and effective.
• Mentor and develop new members of the team in specific plant activities, working with team members in the progression of their skills matrices and developing their skills.
• Assist in project activities as they arise to maintain and optimize the facility
• Play a key role in streamlined changeovers between products and in between batches.
• Drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
• Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
• Benchmark across industries to develop a best in class lean organisation.
• Challenge the status quo with a continuous improvement mindset.
• Utilise real-time data analytics for making decisions on the value stream improvement intiatives.
• Engage in implementing innovative solutions that drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
• Lead and participate in safety, environmental, and quality audits and investigations and implementation of related corrective actions.
• Develop, support and partake in risk assessments, impact assessments, task execution, implementation.
• Remove obstacles from shop floor via troubleshooting, problem solving, and escalating issues as needed.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best comprehend and resolve the root cause
• Report all deviations from safety, quality and environmental requirements.
• Act as an ERT lead.
• Point of contact for the agile team.
• Delegate for Site Shift Lead when out of office.
• Any other duties as and when assigned by the Manager.

What skills you will need:

• Minimum of level 8 Bachelors degree in an engineering or science based discipline or equivalent.
• A masters is desirable.
• Proven leader capability in developing people and teams with at least 5 years leading teams or driving projects forward in a bio pharmaceutical manufacturing.
• Proven record of accomplishments of working for a minimum 5 years in a Pharma/Biopharma company or related industry is desirable.
• Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
• Experience working in a GMP/regulated environment is desirable.
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
• Excellent trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving.
• On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.
• Proficiency with automated systems such as Manufacturing Execution System (MES – PAS X), Systems Applications and Products (SAP), Delta V etc.
• Knowledge of Lean methodologies.
• Training others and/ or leading hands-on or instructor-led training.
• Ability to read, write and understand technical information.
• 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 problem 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.
• Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching.
• Promoting a culture where diversity and inclusion is part of the DNA.
• Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture.
• Strong coaching skills to drive our COMMIT culture.
• Establishes challenging assignments and stretch goals for self and team members and provides management and guidance to team members on prioritization and resource allocation to achieve goals in accordance with established polices and business needs.
• Identifying and communicating risks in area of responsibility and across the site.
• Creating strategies and plans to manage risks within Self Directed work teams and Hubs and across the enterprise.
• Collaborates across the Self-Directed Work Teams and Hubs to coach, mentor and develop the lean and six-sigma capability within the teams to develop their skill-set
• For delivery of the people strategy including recruitment, learning and development and organisational talent reviews collaborates with People Operations Hub to develop a high performing technical organization in Dunboyne.
• Collaborates with cross-functional teams to deliver site objectives.
• For continuous improvement collaborates with Business Excellence peers across the Biologics team in our company and through external forums to drive business excellence and reapplication of best known methods.
• This role is a site based position. This role will involve working shift, on a 24/7 basis

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

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