Job Summary:
The Maintenance Engineer provides technical leadership for maintenance driven engineering projects, support equipment reliability, preventive maintenance, facility-utilities performance, and operational excellence within a regulated pharmaceutical manufacturing environment. The role is responsible for managing engineering initiatives from concept through execution, including equipment upgrades, system modifications, lifecycle improvements, OEE and continuous improvement efforts, ensuring validated state and regulatory compliance are maintained.
This position collaborates closely with Maintenance, Production, Quality Assurance, Compliance, and EHS to ensure all work is executed in accordance with cGMP, GDP, approved procedures, and change management requirements, while supporting safe, efficient, and inspection?ready manufacturing operations.
location: Bartow, Florida
job type: Permanent
salary: $90,000 - 95,000 per year
work hours: 9 to 5
education: Associate
responsibilities:
Duties & Responsibilities
Special Projects & Engineering Initiatives
- Lead engineering projects involving equipment upgrades, facility modifications, new system integrations, and process improvements.
- Develop project scopes, timelines, and documentation.
- Manage contractors, vendors, and internal project resources to ensure projects are executed safely, on time, and within budget.
- Support plant improvement initiatives, utility upgrades, and new technology introduction (automation, robotics, smart maintenance tools, etc.).
- Support Maintenance technicians in responding to equipment issues to minimize downtime in case of escalation or absence in Maintenance Technician team.
- Collaborate with Production Manager on equipment changeovers, setups, and new equipment integration.
- Complete all work accurately in the electronic maintenance system following GDP principles (legible, timely, traceable, contemporaneous, and accurate).
- Collaborate with Production, Quality, and Engineering to resolve recurring equipment, building and/or facility issues.
- Lead and execute engineering projects involving equipment upgrades, facility modifications, new system integrations, OEE and process improvements within a regulated pharmaceutical manufacturing environment.
- Develop and manage project scopes, timelines, risk assessments, and documentation, ensuring alignment with approved procedures and change management requirements.
- Coordinate and oversee contractors, vendors, and internal project resources to ensure work is completed safely, compliantly, on schedule, and within approved budgets.
- Support plant improvement initiatives, utility system upgrades, and the introduction of new technologies (e.g., automation, robotics, predictive and smart maintenance tools), while maintaining validated states where applicable.
- Provide advanced technical support to Maintenance Technicians during escalated equipment issues or in the absence of maintenance coverage, with a focus on minimizing downtime and ensuring safe, compliant operation.
- Collaborate with Production leadership during equipment changeovers, setups, troubleshooting, and new equipment integration, ensuring operational readiness.
- Accurately document all maintenance, repair, and engineering activities in the electronic maintenance management system in accordance with Good Documentation Practices (GDP) (legible, contemporaneous, original, accurate, and traceable).
- Partner with Maintenance, Production, Quality, Validations, and Engineering to identify, troubleshoot, and resolve recurring equipment, utility, or facility issues.
- Ensure all maintenance and engineering activities comply with current Good Manufacturing Practices (cGMP), internal quality systems, approved SOPs, and regulatory expectations.
- Adhere to Good Documentation Practices (GDP) for all work orders, maintenance logs, calibration, and repair records.
- Comply with EHS requirements, including lockout/tagout procedures, permit systems, and facility safety standards.
- Participate in root?cause investigations, support corrective and preventive actions (CAPAs), and provide technical input during audits, inspections, and regulatory inquiries.
- Lead or support the installation, startup, and commissioning of new equipment and systems, including participation in IQ/OQ/PQ activities in collaboration with Quality and Engineering.
- Identify and lead reliability improvements, preventive and predictive maintenance enhancements, and facility-utilities upgrade initiatives to improve asset performance and lifecycle management.
- Serve as a technical resource for maintenance best practices, providing training, mentoring, and guidance to Maintenance Technician I and II personnel.
- Promote standardization, knowledge transfer, and continuous improvement across maintenance, instrumentation & controls, and engineering activities.
- Ensure all maintenance and engineering activities comply with cGMP regulations, internal quality procedures and SOPs.
- Follow Good Documentation Practices (GDP) for all maintenance logs, work orders, and calibration/repair records.
- Adhere to EHS policies, lockout/tagout requirements, and safety standards.
- Participate in root-cause investigations, support CAPAs, and comply with audit and inspection requests.
qualifications:
Required Education:
Associate degree or relevant technical certification (Industrial Maintenance, Electrician, Instrumentation, etc.)
Required Experience:
- A minimum of 10 years of experience in a an industrial or regulated manufacturing environment as a maintenance technician or maintenance engineer.
- 10+ years of experience in a maintenance position in Pharmaceutical/Medical device manufacturing environment or relevant industry such as chemistry or pharmaceutical sciences.
- Prior experience with manufacturing, packaging and automated equipment in regulated FDA environment.
- Experience with cleanrooms or aseptic operations.
skills: Aseptic Technique
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
