Environmental Compliance and Microbiology Technical Specialist

Kindeva Drug Delivery•Brentwood, MO

45d•Onsite

About The Position

The Environmental Compliance (EC) and Microbiology Technical Specialist will be located in St. Louis, MO and work between the Brentwood, MO and Bridgeton, MO facilities to support activities. Standard working hours are 0800-1630, Monday through Friday, but may require support outside of those hours as needed. The EC and Microbiology Technical Specialist is a position responsible for providing site-wide expertise and oversite for microbiology compliance, data review, environmental monitoring (EM), water monitoring programs, laboratory investigations, data integrity, contamination control, inspection readiness, and quality systems within a fast-paced CDMO biopharmaceutical manufacturing environment. This role serves as a technical expert and strategic partner for microbiological quality systems and compliance activities across the QC organization. They will assist in investigations, CAPA development, EM oversight, trend review and analysis, computerized laboratory system reviews, and regulatory inspection readiness. The EC and Microbiology Tech Specialist is responsible for ensuring that microbiological and environmental monitoring programs remain within a state of control, are scientifically sound, risk-based, compliant with global regulatory expectations, and aligned with company quality standards. This position serves as a subject matter expert for EM, contamination control, water monitoring systems, media fill programs, and Environmental Monitoring Performance Qualifications (EMPQ) activities. The role provides technical expertise to support the environmental compliance and microbiology laboratories.

Requirements

Bachelor’s Degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, Biochemistry, or related scientific discipline.
3-5 years of pharmaceutical, biotechnology, or CDMO experience in Quality Control, Microbiology, Environmental Monitoring, Quality Systems, or related functions.
Experience in complex investigations and CAPAs or Change Controls.
Experience supporting inspections, audits, and associated responses.
Experience supporting sterile parenteral manufacturing.
Experience with computerized environmental monitoring systems and validation programs.
Environmental monitoring programs
Aseptic Manufacturing
Utility and water system monitoring
Contamination Control strategies
Media qualification
Microbial Identification
Endotoxin Testing
Bioburden Testing
Sterility Testing
Method Validation and Verification
Quality Systems
cGMP regulations
Data integrity
ALCOA+
Good Documentation Practices (GDP)
OOS/OOT/OOE Investigations
Deviations
CAPA Systems
Change Control
Risk Management
Inspection readiness programs
MODA Environmental Monitoring Systems (or similar)
LIMS
Electronic Quality Systems
Audit Trail Review
Computerized System Validation (CSV)
Exceptional scientific and technical judgement.
Excellent attention to detail.
Ability to recognize scientifically implausible results and data anomalies.
Strong technical troubleshooting.
Ability to assess risk and make sound recommendations.
Investigation and root cause analysis skills.
Excellent written and verbal communication skills.
Ability to recognize compliance risks and implement sustainable solutions.
Proven ability to collaborate effectively across functions and organization levels.
Strong analytical, critical thinking, and decision-making skills.

Responsibilities

Serve as a site SME for microbiological compliance, environmental monitoring, contamination control, and microbiological quality systems.
Support continuous improvement initiatives to strengthen QC quality systems, compliance, and operational efficiency.
Serve as a technical advisor to QC leadership for quality, compliance, and technical decision-making.
Perform and/or oversee technical review of microbiology and EM data as needed.
Ensure compliance with: cGMP requirements, Data integrity requirements, ALCOA+ principles, and Good Documentation Practices (GDP)
Evaluate raw data, electronic records, metadata, audit trails, and laboratory documentation as needed.
Support data integrity remediation activities and risk assessments.
Serve as QC SME for MODA Environmental Monitoring program and workflows to improve operation automation, efficiency and compliance.
Review validation documents associated with MODA implementation and lifecycle management.
Support computerized system validation activities and periodic review.
Provide technical oversite of the EM program.
Author, Review, or Approve EM trend reports and utility reports.
Support EM investigations and corrective actions.
Evaluate environmental monitoring data for adverse trends, shifts, or emerging risks.
Assess water system excursion investigations and related CAPAs.
Identify opportunities to strengthen contamination control strategies and monitoring programs.
Review and approve media fill protocols, reports, risk assessments, and associated microbiological/EM documentation.
Serve as an SME during media fill and EMPQ planning, execution, investigations and regulatory inspections.
Support investigations associated with media fill failures, interventions, EM excursions, and other aseptic qualification events.
Collaborate cross-functionally to ensure successful execution of media fill and EMPQ programs.
Train and qualify EM personnel on media fill and EMPQ sampling techniques, aseptic practices, documentation requirements, and contamination control principles.
Review microbiological and environmental monitoring trends for: Facilities, Utilities, Cleanrooms, Water systems, and Manufacturing operations.
Evaluate data for scientific plausibility and compliance risk.
Identify recurring issues and emerging trends that may impact product quality or patient safety.
Assist with developing recommendations based on trend analysis and risk assessments.
Lead and support complex investigations involving: EM excursions, Water system excursions, OOS, OOT, OOE, Deviations, Contamination events, Data integrity concerns, Laboratory investigations
Assist with root cause analysis using scientific and risk-based methodologies.
Recommend additional testing, monitoring, or investigative actions when necessary.
Ensure investigations are timely, scientifically justified, and compliant with regulatory expectations.
Partner with QA and functional departments to drive closure of quality events.
Assist with development and review of Corrective and Preventative Actions (CAPAs).
Evaluate Capa adequacy and sustainability.
Perform CAPA effectiveness checks and assessments.
Monitor recurrence trends and identify opportunities for systemic improvement.
Serve and an SME as needed during customer audits and regulatory inspections.
Support FDA, EMA, MHRA, and other health authority inspections.
Lead or support associated responses to regulatory observations and commitments.
Ensure microbiology and environmental monitoring programs remain inspection-ready at all times.