The Sterile Technical Services (TS) Engineer plays a key role in maintaining the integrity of sterile drug manufacturing by applying engineering principles to aseptic processing. This position focuses on the design, validation, and continuous improvement of systems and procedures that ensure product sterility, regulatory compliance, and operational reliability.
What You'll Do
- Develop and optimize aseptic compounding workflows, facilities, and equipment to ensure consistent sterility and compliance.
- Lead or support qualification and validation activities, including installation, operational, and performance checks for critical systems.
- Collaborate on the design and lifecycle management of cleanroom environments, HVAC systems, and utility systems impacting sterility.
- Investigate deviations and contamination events using root cause analysis and support corrective and preventive actions (CAPA).
- Prepare and review technical documentation such as SOPs, validation protocols, risk assessments, and investigation reports.
- Support media fill programs, environmental monitoring, and aseptic process simulations to verify sterility assurance practices.
- Apply risk management methodologies like FMEA to identify and reduce risks to product quality.
- Train technical and operations staff on aseptic techniques, equipment use, and contamination control practices.
- Support regulatory inspections, audits, and remediation efforts with accurate, compliant documentation.
- Contribute to process scale-up, technology transfer, and new product implementation with a focus on validation readiness.
Requirements
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Pharmacy, or a related technical field.
- 1–3+ years of experience in sterile compounding, pharmaceutical manufacturing, or regulated cleanroom operations.
- Understanding of cGMP, USP <797>, and, where applicable, USP <800> standards.
- Hands-on experience with sterilization methods, aseptic processing, and cleanroom practices.
- Proven ability to support equipment qualification, process validation, and lifecycle compliance.
Preferred Qualifications
- Master’s degree in Engineering or Pharmaceutical Sciences.
- Experience with isolators, RABS, single-use systems, or automated aseptic technologies.
- Training or certification in Lean, Six Sigma, or formal risk assessment methods.
- Direct involvement in FDA inspections, audit responses, or quality remediation projects.
Benefits
- Competitive salary and equity compensation for eligible roles
- Medical, dental, and vision insurance coverage
- Parental leave and employee stock purchase program (ESPP)
- 401(k) plan with employer matching
