Validation Engineer (Aseptic Qualification and EMPQ)

Trinity Consultants, Life Sciences is a consulting firm providing expertise to the pharmaceutical and biotechnology industries. With locations across the US, Trinity Consultants participates in almost every facet of global pharmaceutical and biotechnology facility, manufacturing, and quality system projects.

Trinity’s services include validation and compliance consulting, aseptic processing support, environmental monitoring qualification, commissioning and qualification (CQV), contamination control strategy development, and operational readiness support for distinguished biotechnology and pharmaceutical manufacturing companies.

The Validation Engineer (Aseptic Qualification and EMPQ) provides technical leadership and execution support for sterile and aseptic manufacturing operations, with a focus on cleanroom qualification, environmental monitoring performance qualification (EMPQ), aseptic process simulations (APS/media fills), and airflow visualization (smoke studies). This role is critical to ensuring facility and process readiness for clinical and commercial manufacturing within highly regulated environments, including cell and gene therapy.

The position requires strong collaboration across Validation, Microbiology, Quality Assurance, Manufacturing, and Engineering to ensure compliant, inspection-ready aseptic operations.

Responsibilities

Aseptic Qualification & Sterility Assurance Support

• Provide validation engineering support for aseptic processing operations in ISO-classified cleanrooms and biological safety cabinets (BSCs).
• Support contamination control initiatives aligned with regulatory expectations for sterile manufacturing and advanced therapy facilities.
• Partner with cross-functional teams to ensure facility and operational readiness for aseptic manufacturing campaigns.

Environmental Monitoring Performance Qualification (EMPQ)

• Lead the development, authoring, and execution of EMPQ protocols for ISO 7 processing rooms and supporting classified environments.
• Define sampling strategies, locations, frequencies, and acceptance criteria based on risk, process flow, and regulatory requirements.
• Execute EMPQ studies under both at-rest and in-operation conditions, ensuring robust qualification of aseptic environments.
• Author and review EMPQ summary reports, including data evaluation, excursion handling, and deviation documentation.

Aseptic Process Simulation (APS / Media Fills)

• Support the planning, execution, and documentation of aseptic process simulations to qualify operator practices and aseptic workflows.
• Ensure APS activities include appropriate worst-case interventions and are aligned with site contamination control strategies.
• Collaborate with QA and Manufacturing to support successful media fill execution, review, and closure.

Smoke Studies & Airflow Visualization

• Plan and execute smoke studies and airflow visualization assessments for BSCs and ISO 7 processing rooms.
• Evaluate airflow patterns, turbulence, operator interaction effects, and protection of critical processing zones.
• Document results in formal reports and support remediation activities where airflow deficiencies are identified.

Protocol Development & Validation Documentation

• Author, execute, and review controlled validation documentation, including:
• Qualification protocols and reports
• EMPQ and APS documentation
• Risk assessments and contamination control-related studies
• Change control and lifecycle qualification documents
• Ensure compliance with cGMP requirements and regulatory guidance, including EU GMP Annex 1 and FDA aseptic processing expectations.
• Serve as a technical contributor during internal audits and regulatory inspections.

Continuous Improvement & Cross-Functional Collaboration

• Identify opportunities to strengthen aseptic control, environmental monitoring performance, and cleanroom operational practices.
• Support investigations into environmental monitoring excursions and aseptic deviations, contributing to root cause analysis and CAPA development.
• Collaborate with clients, vendors, and internal teams to support ongoing qualification and contamination control improvements.

Qualifications

Education

• Bachelor’s degree in Engineering, Microbiology, Biotechnology, or a related scientific discipline.

Experience

• 3–7+ years of experience in a GMP-regulated sterile manufacturing, biologics, or cell and gene therapy environment.
• Demonstrated hands-on experience executing aseptic qualification activities, including:
• EMPQ protocol writing and execution
• Cleanroom qualification for ISO 7 / Grade B environments
• Aseptic process simulation (APS/media fills)

Technical Experience

• Strong understanding of aseptic processing principles, environmental monitoring programs, and contamination control expectations.
• Experience with viable and non-viable monitoring methods, including:
• Active air sampling
• Settle plates
• Surface/contact sampling
• Glove/fingertip sampling
• Hands-on experience supporting airflow visualization/smoke studies for BSCs and classified processing suites.

Knowledge & Skills

• Strong understanding of cGMP, sterility assurance, and regulatory expectations (FDA, EMA, EU Annex 1).
• Excellent technical writing and documentation skills, with experience producing inspection-ready protocols and reports.
• Strong analytical and problem-solving skills with ability to support deviation investigations and CAPA development.
• Proficiency with Microsoft Office and validation documentation systems.
• Preferred Qualifications
• Experience in cell therapy or gene therapy manufacturing environments with high-intervention aseptic operations.
• Prior participation in regulatory inspections involving EMPQ, APS, or aseptic qualification topics.
• Familiarity with contamination control strategy development and Annex 1 implementation.
• Certification or experience in Lean, Six Sigma, or structured problem-solving methodologies.
• Project execution experience supporting cross-functional client teams.