Director, Engineering & Maintenance

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

The Director of Engineering & Maintenance is responsible for leading GRAM's engineering and maintenance functions with a primary focus on manufacturing reliability, equipment performance, technical problem-solving, maintenance excellence, deviation reduction, and continuous improvement across sterile pharmaceutical operations. This role serves as the organization's technical leader for engineering and equipment reliability, ensuring manufacturing assets operate safely, compliantly, and efficiently while supporting customer commitments and business objectives. The Director will drive a culture of proactive maintenance, disciplined root cause analysis, operational excellence, and continuous improvement. This position excludes responsibility for Facilities, Utilities, Capital Projects, Building Infrastructure, and Grounds Services, which are managed separately. This is not a remote role.

Non-Negotiable Requirements:

• Possess Bachelor of Science degree in Engineering. Bachelor's degree in Mechanical, Electrical, Chemical, Industrial, Manufacturing Engineering, or other related technical field accepted.
• 10+ years of progressive engineering and/or maintenance leadership experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Demonstrated success leading engineering and maintenance organizations.
• Must have proficient computer skills in Microsoft Word, Excel, Outlook; and PowerPoint.
• Knowledge or skill in working with a CMMS system.

Preferred Requirements:

• Master's Degree in Engineering or technical field.
• Experience supporting sterile manufacturing or aseptic processing environments strongly preferred.

Responsibilities Include (but are not limited to):

• Build a high-performance culture and team focused on accountability, technical excellence, responsiveness, and continuous improvement.
• Provide leadership, coaching, and development to engineering and maintenance personnel.
• Establish departmental goals aligned with GRAM's strategic, operational, and quality objectives.
• Provide engineering and maintenance support during manufacturing activities.
• Develop and execute preventive and predictive maintenance programs to maximize equipment uptime and reliability.
• Drive improvements in planned maintenance compliance, mean time between failures (MTBF), mean time to repair (MTTR), equipment uptime, maintenance backlog management, and spare parts management.
• Utilize structured problem-solving methodologies including 5 Why Analysis, Fishbone Diagrams, Fault Tree Analysis, DMAIC, and Failure Mode and Effects Analysis (FMEA).
• Review investigations and CAPAs to ensure sustainable corrective actions are implemented.
• Drive elimination of recurring failures and repeat deviations.
• Establish and monitor key performance indicators including equipment uptime, deviation reduction, repeat failure rates, maintenance compliance, overall equipment effectiveness (OEE), CAPA effectiveness, NCR trends, and batch success rates.
• Utilize performance data to identify opportunities for continuous improvement. Establish maintenance KPIs and performance standards.
• Present operational performance updates and strategic improvement plans to Executive Leadership.
• Ensure engineering and maintenance activities comply with FDA regulations, GMP requirements, data integrity expectations, and internal quality systems.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.