Facility Engineer

Facility Engineer Apollo Care, LLC Columbia, MO Job Details Full-time $75,000 - $100,000 a year 11 hours ago Benefits Health insurance Dental insurance Paid time off Parental leave Employee assistance program Vision insurance Life insurance Qualifications Quality control corrective actions Bachelor's degree in mechanical engineering Six Sigma Certification Preventative hardware maintenance Chemical Engineering HVAC system maintenance Procedural guides Calibration Technical documentation 5 years Pharmaceutical regulatory compliance Safety regulations Engineering Bachelor's degree in biomedical engineering Mechanical Engineering Safety standards in production Compliance audits & assessments Six Sigma methodology implementation Biomedical Engineering Corrective and preventive actions (CAPA) Equipment malfunction troubleshooting Manufacturing standard operating procedures Quality assurance audits Project management Bachelor's degree in engineering Bachelor's degree Pharmaceutical plant experience Bachelor's degree in chemical engineering Cleanroom Autoclave Pneumatic systems Maintenance management Quality audits Manufacturing Root cause analysis Senior level Cross-functional collaboration Lean Six Sigma Certification Chemical engineering Compounding medications Regulatory compliance management Cross-functional communication FDA regulations Engineering validation

Full Job Description Position Summary:

The Facility Engineer is responsible for maintaining, monitoring, and improving facility systems and equipment used in a CGMP-compliant 503B outsourcing facility. This role ensures all biomedical equipment and critical utilities meet regulatory requirements and support sterile pharmaceutical compounding operations. The engineer partners with Quality Assurance, Maintenance, Validation, and Production teams to support manufacturing and compliance objectives.

Key Responsibilities:

Oversee operation and maintenance of facility systems including HVAC (ISO-classified cleanrooms), automated production equipment, compressed air, and environmental monitoring systems. Maintain and support qualification/validation of biomedical and production equipment (e.g., autoclaves, isolators, depyrogenation ovens, filling lines, biosafety cabinets). Troubleshoot and resolve issues with facility and biomedical equipment, ensuring minimal disruption to sterile operations. Lead or support deviations, root cause investigations, and corrective and preventive actions related to all processes. Participate in internal and external audits; ensure compliance with

FDA 21 CFR

Part 210/211 and USP , , and (if applicable). Develop and maintain preventive maintenance (PM) schedules and calibration programs for all GMP-critical equipment. Author or review engineering documentation including equipment User Requirement Sheets, Install, Operational, and Performance Qualification protocols, Standard Operating Procedures, and manage the change control program. Ensure all engineering work is performed in compliance with safety regulations and CGMP standards. Assist in facility expansions, equipment upgrades, and capital projects. Support cleanroom design, airflow visualization (smoke studies), and other environmental controls required for sterile operations. Assist with compounding production day activities on the automated equipment line.

Qualifications:

Bachelor's degree in biomedical, mechanical, chemical, or facilities engineering or related field. 5+ years of engineering experience in a CGMP-regulated environment, preferably sterile pharmaceutical manufacturing or 503B outsourcing. Experience with facility systems such as HVAC, compressed air, automated equipment lines, and ISO-classified cleanrooms is preferred. Knowledge of

FDA CGMP

regulations, aseptic processing, and quality systems is preferred. Experience with equipment qualification/validation and change control processes. Strong hands on problem-solving skills, attention to detail, and cross-functional collaboration. The ability to spearhead project management initiatives utilizing Lean/ Six Sigma certification.

Reporting Structure:

This position reports directly to the Apollo Care's President, but will receive tactical project engagement from the Director of Quality.

Pay:

$75,000.00 - $100,000.00 per year

Benefits:

Dental insurance Employee assistance program Health insurance Life insurance Paid time off Parental leave Vision insurance

Education:

Bachelor's (Required)

Work Location:

In person