Validation Engineer

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BLOC is a privately held development-stage biopharmaceutical company with a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Our culture is enthusiastic, proactive, and hard-working. We encourage critical thinking, working from the fundamentals, and exploring new ideas. Check us out at

We are looking for a motivated, organized, and hands‑on Validation Engineer to support clinical manufacturing readiness for GMP facility systems, utilities, equipment, and processes. This role is well suited for candidates with 0–5 years of relevant experience, including early-career candidates building CQV fundamentals and candidates with direct hands‑on execution experience who are ready to own defined work streams with appropriate oversight.

You will help create, organize, execute, and close out commissioning and qualification documentation that supports clinical manufacturing operations. The position will emphasize generation and execution of IQ/OQ/PQ protocols, commissioning activities, discrepancy and deviation management, coordination with system owners and vendors, and close collaboration with Engineering, Manufacturing, Quality, Facilities, and Operations teams.

• Generate, review, revise, and execute CQV documentation, including User Requirements Specifications (URS), Risk Assessments, Impact Assessments, Requirement Traceability Matrices (RTMs), Commissioning Protocols, IQ/OQ/PQ protocols, discrepancy documentation, and summary reports.
• Execute commissioning and qualification protocols in the field for GMP manufacturing equipment, utilities, laboratory equipment, computerized systems and related support systems.
• Support the protocol lifecycle from drafting and routing through execution, data review, discrepancy resolution, report generation, and closeout.
• Support facility startup and commissioning activities, including system walkdowns, turnover package review, P&, punch list management, component verification, operational readiness, and field coordination.
• Conduct or support risk assessments and impact assessments, establish or document system boundaries, and translate assessment outputs into practical CQV deliverables under appropriate technical and Quality oversight.
• Author, review, and revise standard operating procedures, work instructions, and supporting GMP documentation as needed.
• Investigate, document and support the resolution and closeout of discrepancies and deviations, including impact assessment, corrective actions, and retest activities as appropriate.
• Coordinate with Engineering, Manufacturing, Quality, Facilities, Operations, system owners, and external vendors to plan execution windows, resolve field issues, and drive assigned deliverables to completion.
• Own defined CQV deliverables, equipment packages, or execution work streams commensurate with experience, with guidance from senior technical and Quality team members.

• Bachelor’s degree in engineering, life sciences, or an equivalent technical discipline preferred.
• 0–5 years of experience in commissioning, qualification, CQV, manufacturing, engineering, facilities, operations, quality, or another GMP technical role; candidates with direct hands‑on CQV execution experience are strongly encouraged to apply.
• Experience in clinical manufacturing, start-up, or early-stage biopharmaceutical environments is a plus, particularly where responsibilities included both documentation and field execution.
• Hands‑on technical experience involving manufacturing equipment, utilities, process systems, laboratories, computerized systems, temperature‑controlled units, or GMP documentation is valued.
• Strong technical writing skills with the ability to produce clear, accurate, inspection‑ready protocols, forms, reports, SOPs, and supporting documentation.
• Comfortable performing hands‑on protocol execution, including observing equipment operation, recording data, following procedures, coordinating with system owners, and escalating issues appropriately.
• Experience with facility…