Environmental Compliance & Microbiology Specialist

Kindeva Drug Delivery; Missouri; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive base salary

Performance bonus

Benefits package

Job summary

Kindeva Drug Delivery is seeking a highly skilled EC and Microbiology Technical Specialist to join our St. Louis team.

The role provides site-wide microbiology compliance expertise, EM oversight, and data integrity initiatives in a fast-paced biopharmaceutical CDMO environment. Responsibilities include investigations, CAPA development, trend analysis, VALIDATION activities, and collaboration with QA to maintain inspection readiness.

Qualifications

• Bachelor’s degree in microbiology, biology, biotechnology, pharmaceutical sciences, biochemistry, or related discipline.
• 3–5 years of pharmaceutical, biotechnology, or CDMO experience in QC, Microbiology, Environmental Monitoring, or Quality Systems.
• Experience supporting inspections, audits, and regulatory responses.
• Experience with sterile parenteral manufacturing and environmental monitoring.
• Knowledge of cGMP, data integrity, ALCOA+, GDP.

Responsibilities

• Serve as site SME for microbiological compliance, environmental monitoring and contamination control.
• Oversee EM data review, trend analysis, and regulatory inspections readiness.
• Support CAPAs, investigations, and change controls.
• Lead or support media fill and EMPQ activities and related investigations.
• Assist with documentation, risk assessments, and data integrity remediation.

Skills

Analytical thinking

Attention to detail

Investigation skills

Cross-functional collaboration

Education

Bachelor’s Degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, Biochemistry, or related scientific discipline

Tools

MODA EM Systems

LIMS

Electronic Quality System

CSV Validation

Job description

Kindeva Drug Delivery is seeking a highly skilled EC and Microbiology Technical Specialist to join our St. Louis team.

The role provides site-wide microbiology compliance expertise, EM oversight, and data integrity initiatives in a fast-paced biopharmaceutical CDMO environment. Responsibilities include investigations, CAPA development, trend analysis, VALIDATION activities, and collaboration with QA to maintain inspection readiness.