Qualification & Validation Senior Specialist

Qualification & Validation Senior Specialist

Job Category
:
Default

Requisition Number
: QUALI
006069

• Posted :
  August 26, 2026
• Full-Time
• On-site

Showing 1 location

NJ - Bloomsbury Site
519 NJ-173
Bloomsbury, NJ 08804, USA

Our Qualification and Validation Senior Specialist, plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include driving compliance at a high level with Qualification and Validation policies, procedures, and controls across all QuVa sites that ensure that quality and performance of products, processes, equipment, and facilities conform to established standards, specifications, and regulatory guidelines.

The role is responsible for application, qualification, and validation of processes, equipment, control schemes, process optimization and qualification of alternate parts, across all QuVa sites. Activities include startup, demonstration, commissioning, qualification, and validation plans for the entire operations lifecycle. This position will support all facilities activities, equipment onboarding and utilization, and operations, including process improvements and troubleshooting. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Qualification and Validation Senior Specialist Does Each Day:

• Provides prospective evaluation, technical input, authoring, and review of qualification and validation master plans, commissioning documents, protocol content and execution strategy, ensuring compliance with corporate and regulatory standards
• Provides technical support and guidance on equipment, facilities, and utilities qualification by authoring and reviewing protocols, identifying gaps, and establishing action plans for those items considered critical to meet the local requirements for qualification
• Provides technical support and guidance on process qualification and validation by authoring and reviewing protocols, identifying gaps, and establishing action plans for those items considered critical to meet the local requirements for process qualification and validation
• Provides direct support for the execution process of qualification and validation protocols.
• Supports site inspections from regulatory bodies, providing comprehensive technical background and history related to qualification and validation efforts KEEP
• Writes and executes technical documents such as IQ’s, OQ’s, PQ’s, Engineering Studies, Summary Reports, Etc.
• Writes, evaluates, and resolves deviations that occur during protocol execution
• Independently leads higher level projects related to qualification/validation activities across sites to ensure proper and timely completion
• Reviews and approves protocol templates, executes protocols, and summary reports to ensure all appropriate criteria and test cases are captured and met to be compliant with industry standards, mfg. specs and QuVa requirements
• Leads execution and provides training when applicable across sites for smoke study activities including making sure these studies capture the process and aseptic technique correctly
• Assists or leads in creating/writing Standard Operating Procedures (SOPs), Work Instructions (Wis), and Incident Reports (IR’s) for equipment and procedures related to qualification/validation activities
• Supports the proper continuous functionality of qualified/validated equipment and processes supporting the automation/facilities team when complicated issues occur
• Onboarding of equipment to include evaluating the equipment criticality
• Assists in Computer Software Validation (CSV) periodic reviews, gap assessments, and validation activities when required
• Provides training in validation and qualification concepts to all personnel involved with the execution of qualification and validation activities
• Participates in high level troubleshooting activities related to equipment and processes
• Complies with 503B guidelines, ISO standards, Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and company policies
• Conducts investigations, root cause analyses, and…