Job Description

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

The Head of Engineering is responsible for overseeing the maintenance, qualification, and validation of the facilities, utilities and equipment that are required to produce high quality and compliant biopharmaceuticals. This key leadership position reports to the Site Head and is a member of the site leadership team. This individual will hold responsibility for leadership of the facilities engineering, maintenance, and validation engineering teams, developing and implementing programs to ensure that projects are completed in accordance with all safety, quality, and applicable regulatory requirements. The Head of Engineering will drive appropriate performance KPIs, managing timelines and working with site stakeholders to successfully complete deliverables. This individual will work with the site director and other members of the leadership team to identify and prioritize areas for improvement and encourage good change management practices, driving strategic direction to develop and implement business initiatives, site plans, and key global strategies.

• Responsible for overseeing maintenance, qualification and validation of facilities, utilities, and equipment, and maintaining the requalification and calibration program
• Manage and support Preventative Maintenance programs, planned facility shutdowns, and proactive equipment reliability assessments to ensure maximum plant capacity
• Support new equipment installation and start-up
• Identify and maintain inventory of replacement parts for critical equipment
• Promote a culture of safety, quality, and compliance, and achieve continuous improvement through Operational Excellence initiatives
• Create and track metrics demonstrating successful management of areas of responsibility
• Identify and mitigate risks that could adversely impact project outcomes and timely delivery of product to customers
• Participate in the design, justification and execution of capital projects for manufacturing facilities and equipment
• Responsible for compliance documentation, including risk assessments, qualifications, validations, required environmental reporting, and the maintenance of required local, state, and federal permits and reporting
• Assure that out-sourced facility maintenance and building and grounds services are performed at a high quality level, in a timely fashion, and within budget cost constraints. Ensure Contractors are trained and comply with GMP and internal procedures
• Develop yearly financial plan and manage areas of responsibility within approved budget
• Ensure the structure and staffing of engineering department is adequate to meet site objectives
• Establish and maintain training requirements for engineering staff
• Attract, develop, and retain skilled talent
• Coach and train employees in an effective, business appropriate manner, providing a strong avenue of communication and maintaining a foundation of respect and dignity
• Collaborate with other department heads and senior management to develop and implement site-wide policies and procedures
• Interact on a daily basis with customers, business development, project management, HR, Finance, Quality, EHS, Process & Analytical Development, MSAT, Manufacturing, and Supply Chain
• Participate in customer and regulatory audits as needed

Who you are:

Minimum Qualifications:

• Bachelors degree in Engineering, Construction Management, or other related technical, science, or engineering field
• Minimum 10 years experience in facilities and/or validation engineering in a cGMP environment
• Minimum 5 years experience in a leadership role for technical functions
• Understanding of manufacturing equipment and systems as well as support utilities such as HVAC, high purity water, and process heating/cooling
• Knowledge of relevant regulatory requirements and guidelines and Quality Systems as they relate to GMP operations

Preferred Qualifications:

• Proven track record of success in managing and leading teams in the biopharmaceutical industry
• Strong analytical and problem-solving skills
• Ability to think strategically and make effective decisions
• Strong leadership and mentorship abilities
• Operational Excellence certification

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.

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