Bachelor's degree in a relevant field or equivalent experience required.
4+ years managing production and facilities maintenance in a cGMP or FDA regulated environment; 8+ years preferred.
Advanced problem-solving skills, with Six Sigma and Lean training preferred.
Strong coaching and mentoring abilities.
Excellent organizational and matrix management skills.
Good understanding of ladder logic and troubleshooting principles.
Proficient in Blue Mountain BMRAM CMMS and Microsoft 365 tools.
Responsibilities
Lead and direct maintenance functions for physical plant and manufacturing equipment.
Drive continuous improvement initiatives to minimize equipment downtime.
Implement reliability strategies to enhance technician capabilities.
Utilize visual factory concepts to boost asset utilization and performance.
Oversee maintenance work orders for compliance and accuracy.
Coordinate biannual facility shutdowns for preventative maintenance activities.
Manage equipment and building technical issues throughout project life cycles.
Benefits
Smart healthcare coverage options that reward wellness.
Flexible Spending & Health Savings Accounts available.
Dental & Vision insurance provided.
Employer Paid Life Insurance and Employee Assistance Program.
Short Term & Long-Term Disability Insurance included.
Up to 4% 401K Matching, fully vested from day one.
Generous Paid Time Off options including vacation and holidays.
$5,250 Annual Tuition Reimbursement after 6 months of employment.
$1,000 Referral Bonus Program with no limit on referrals.
Eligibility for an annual bonus program.
Full Job Description
The Maintenance Manager reports to the Vice President of Engineering and is responsible of all maintenance functions of physical plant, utilities and manufacturing equipment including aseptic filling and packaging. Responsible for planning, assigning, and directing a team of maintenance technicians. Supervise and plan all maintenance, repairs, equipment upgrades, and projects performed over multiple shifts. Review and approve all maintenance work orders for accuracy and compliance.
Essential Functions:
This description is intended to be illustrative of the major duties performed by the employee assigned to this position.
Initiate and drive continuous improvement of maintenance methods and/or projects to reduce equipment downtime and reactive maintenance response.
Deploy strategies in reliability that build maintenance and technician capabilities.
Utilize visual factory concepts to improve and communicate asset utilization and plant performance.
Ensure proper utilization of Blue Mountain Computer Maintenance Management System (CMMS)
Develop and deploy 24/7 FMS alarm monitoring, response, and acknowledgement.
Communicate and collaborate cross-functionally to assist the F & E team in solving operational issues.
Ensure all company and site Engineering policies and procedures are adhered to.
Report appropriate project and work task status to the VP Engineering, project team members and project management personnel.
Lead biannual site facility shutdown coordinating all preventative maintenance and calibration activities.
Manage and resolve equipment and building technical issues or changes arising throughout the project life cycle while also ensuring the overall project objectives of scope, cost and schedule are adhered to.
Ensure all facilities, utilities and / or equipment are handed over effectively to end users.
Investigate and troubleshoot equipment failures and complete appropriate deviation and CAPA action items as assigned.
Examine monthly expenses and approve monthly cost forecasts. Prepare annual expense budget for maintenance.
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
Other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
Directly hire and lead a team of technicians.
Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
Conduct regular 1:1's to address performance, feedback and relationship building.
Identify training and development needs within the team and facilitate as able.
EXPERIENCE AND NECESSARY COMPETENCIES:
Bachelor's degree in a relevant field and/or equivalent experience required.
4+ years' experience in managing production and facilities maintenance for a cGMP or FDA regulated environment required. 8+ years preferred.
Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
Excellent personal coaching skills
Strong results orientation.
Excellent matrix management skills and organizational skills.
Good understanding of ladder logic and its underlying principles.
Good Troubleshooting and Root cause analysis.
Proficient in Blue Mountain BMRAM CMMS preferred.
General understanding of pharma automation and utilities preferred.
Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines required.
Proficient written, verbal and oral English communication skills are required.
Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements:
Ability to stand or sit for extended periods of time.
Ability to lift, push and pull up to 50 pounds periodically.
Ability to maintain a gowning qualification.
Ability to work off-shifts and/or weekends when required.
Benefits:
Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
Flexible Spending & Health Savings Accounts (FSA & HSA) available
Dental & Vision insurance
Employer Paid Life Insurance & Employee Assistance Program
Short Term & Long-Term Disability Insurance
Up to 4% 401K Matching (100% vested on day one!)
Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
$5,250 Annual Tuition Reimbursement after 6 months
$1,000 Referral Bonus Program with no limit
Eligible for annual bonus program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
About Leiters
Leiters is a pharmaceutical company that specializes in developing and manufacturing sterile injectable products. The company was founded in 1926 and is headquartered in McKinney, Texas. Leiters has a state-of-the-art manufacturing facility that is FDA-approved and operates under current Good Manufacturing Practices (cGMP). The company's products are used in hospitals, surgery centers, and clinics across the United States. Leiters is committed to providing high-quality products and exceptional customer service to its clients.
