Job Description

A fantastic opportunity has arisen for a Site Engineering Director. This position will drive engineering, maintenance, facilities, utilities and projects expertise to deliver for clinical and commercial manufacturing at our Biologics commercialisation facility at Dunboyne. Reporting to the Site Operations Lead, the Site Engineering Director will provide leadership and technical expertise to Biologics drug substance (DS) clinical and/or commercial manufacturing in addition to technical transfer, PPQ and approval of new products.

Bring energy, knowledge, innovation to carry out the following

Serve on the Site Leadership Team to develop and deliver toward site priorities.Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, adherence to all regulatory expectations (GMP and EHS) and permanent inspection readiness programs.Manage, coach, and mentor the site engineering team, including Maintenance, Utilities, Facilities, Engineering Center of Excellence and Small Project teams.Provide engineering excellence for the site through design, construction, validation, start up, technology transfer and clinical and commercial manufacturing.Lead and/or support various site functional and cross functional communication and escalation structures.Plans and directs all aspects of engineering/facilities/utilities/project activities and ensures that all engineering projects, initiatives and processes are in conformance with established policies, standards and objectives.Establish and deliver on KPI’s in a timely manner, including maintenance adherence, facility start up, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, Right First Time, and timely documentation closure.Ensure facilities, engineering and any new project milestones are achieved through planning and execution of integrated overall program schedule.Provide clear direction and definition of engineering and any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis.Resolve resource constraints and support resource needs and changes.Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders.Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process.Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. Manage financial forecasts and workload to achieve departmental headcount and cost improvementsManage and develop team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to grow and succeed.Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes.Own accountability for site engineering positions on various site Councils and governance; eg, Quality Council, EHS Council, Operational Readiness, Quality Risk Management, Finance Council, etc.Participate and Comply with our Manufacturing Division Quality Management System (QMS) and EHS requirements, including topic ownership, effective implementation and continuous improvement, as applicable.

Preferred Qualification and Experience

Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies).Demonstrated leadership with at least 10 years leading in a cross-functional environment.Demonstrated biotech/vaccines/pharma manufacturing site, project or other relevant experience.

General/Technical Competencies

Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high-performance organizational culture that accommodates rapid growth and highly dynamic operating execution.The desire to continuously learn, improve and grow, and cultivate continued development within the team.Innovative thinker, with excellent decision-making and problem-solving skills.Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of Dunboyne.Ability to influence across organizational layers, as well as outside the site and externally with partners.Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives.A great communicator, decisive decision maker with a proven ability to deliver excellence.Proven capabilities in engineering and a proven track-record in project management.Proven capabilities and knowledge of Biologics manufacturing.Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.Knowledge of global and company health authority regulations and applicable systems & GMP and EHS requirements.  Experience engaging with regulatory agencies including in on-site inspections.Sound judgment and comfortable operating in a challenging, fast-paced, and sometimes ambiguous environment.Knowledge of Environmental and Safety regulatory/code requirements to Irish, European and International Codes, Standards and Practices related to Facilities, Equipment and Maintenance.

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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):

Job Posting End Date:

01/28/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R329699