Principal Specialist, Global Engineering Validation QA

Position Summary

This is a global role providing independent Global QA oversight across biologics manufacturing sites. The role focuses on global governance, cross-site alignment, and risk-based oversight of engineering validation, process validation, sterile

drug product manufacturing, sterility assurance, and manufacturing controls. It partners with global functions and site teams to establish consistent quality expectations, assess and challenge site strategies, identify and escalate significant quality or compliance risks, and support inspection readiness across the product lifecycle. The role does not own routine site-level

execution or document approval.

The ideal candidate is an experienced QA professional with a strong sterile drug product background, practical quality management experience, and the ability to provide independent Global QA oversight across multiple sites. The candidate should be able to assess and challenge site validation and manufacturing control strategies, align global quality expectations, and identify and escalate significant quality or compliance risks.

Role Focus

Independent Global QA oversight of facilities, utilities, equipment, computerized systems, and validation lifecycle activities

across sites.

Global QA oversight of process validation, sterile manufacturing controls, sterility assurance, contamination control, and

aseptic process validation.

Establish and maintain global quality expectations, procedures, standards, and governance practices, and drive

practical cross-site alignment and continuous improvement.

Key Responsibilities

Engineering Validation QA Oversight

Provide independent Global QA oversight of qualification and validation strategies for facilities, utilities, equipment, instruments, computerized systems, and related lifecycle management across sites.

Review key validation documents, including qualification and validation plans, protocols, reports, engineering change controls, and associated quality assessments.

Ensure validation decisions are risk-based, scientifically justified, GMP-compliant, and inspection-ready.

Manufacturing

Control & Process Validation QA Oversight

Provide Global QA oversight of manufacturing control strategies, including critical process controls, in-process controls, sterility assurance, contamination control, and batch execution consistency.

Assess and challenge process validation strategies, including aseptic process simulation, acceptance criteria, continued monitoring expectations, and lifecycle change impact assessments.

Provide risk-based oversight of significant manufacturing deviations, process excursions, atypical events, and investigation outcomes, with focus on systemic impact, cross-site relevance, and adequacy of corrective actions.

Global Standards & QMS Maintenance

Develop, maintain, and improve global validation procedures, templates, quality standards, and governance practices; drive cross-site implementation and harmonization; and assess the impact of emerging regulatory expectations.

Compliance & Inspection Readiness

Provide global subject-matter support for audit and inspection readiness related to engineering validation, process validation, sterile manufacturing, and manufacturing controls.

Confirm that significant validation and manufacturing control decisions are supported by appropriate evidence, traceability, and defensible scientific and quality rationale.

Cross-functional Collaboration

Partner with Validation, Engineering, Manufacturing, MSAT, QC, Site QA, and global QMS teams to align global expectations, provide independent QA oversight, and address significant quality or compliance issues without assuming site execution ownership.

Drive cross-site knowledge sharing, benchmarking, and practical harmonization of validation, sterility assurance, contamination control, and manufacturing control practices.

Minimum Requirements

Bachelor’s degree or above in Pharmaceutical Sciences, Biotechnology, Engineering, or a related discipline.

10+ years of experience in QA, Manufacturing QA, Validation, Process Validation, or related GMP functions within the pharmaceutical or biopharmaceutical industry. Working knowledge of GMP expectations and regulatory frameworks.

Relevant experience in sterile drug product manufacturing is required, with demonstrated experience across multiple areas, including qualification and validation of sterile manufacturing facilities, utilities, and equipment; sterility assurance and quality management; contamination control; and aseptic process validation.

In-depth knowledge of aseptic process simulation (APS), airflow visualization studies (AVS), vaporized hydrogen peroxide (VHP), decontamination, and contamination control strategy (CCS) is required, together with demonstrated practical experience in evaluating, approving, or providing QA oversight of these programs.

Practical experience with validation lifecycle activities for facilities, utilities, equipment, computerized systems, or manufacturing process validation programs.

Demonstrated quality management experience, including practical involvement in quality governance, deviation and CAPA

oversight, change control, quality risk management, inspection readiness, and escalation of significant quality or compliance risks.

Good English communication skills and demonstrated ability to influence, challenge, align, and collaborate with global and site stakeholders in a cross-cultural environment.

Preferred Experience

Experience within a global or corporate quality organization is preferred.

Familiarity with PDA Technical Reports, ISPE guidance, or similar industry practices is a plus.