Quality Assurance Validation Specialist

The Quality Assurance Validation Specialist provides Quality Assurance oversight of qualification and validation lifecycle activities supporting clinical and commercial manufacturing operations. This role is responsible for reviewing, approving, and assessing validation deliverables associated with facilities, utilities, equipment, cleaning, process validation, computerized systems validation, and ongoing lifecycle management programs.

The position partners closely with Manufacturing, Engineering, Quality Control, Technical Operations, Regulatory Affairs, and Quality Systems to ensure qualification and validation activities are executed in accordance with applicable regulatory requirements, company procedures, and industry best practices.

Duties and Responsibilities

Provide Quality Assurance oversight of qualification and validation activities supporting clinical and commercial manufacturing operations.
Review and approve qualification and validation lifecycle deliverables including:
Validation Master Plans
Risk Assessments
User Requirements Specifications (URS)
Commissioning and Qualification protocols and reports
Process Validation protocols and reports
Cleaning Validation protocols and reports
Computerized System Validation documentation
Continued Process Verification documentation
Periodic Review reports
Requalification assessments
Ensure validation activities comply with applicable cGMP regulations, industry guidance, and internal procedures.
Support maintenance of the validated state through lifecycle monitoring, change management, periodic review, deviation assessment, and risk-based decision making.
Provide QA review and approval support for validation-related deviations, CAPAs, change controls, and investigations.
Assess validation strategies for compliance with applicable regulatory requirements and industry expectations.
Partner with cross-functional teams to evaluate the impact of proposed changes on validated systems, processes, and equipment.
Support validation aspects of technology transfer, process scale-up, PPQ, and commercial readiness initiatives.
Participate in internal audits, client audits, and regulatory inspections involving qualification and validation programs.
Support responses to audit observations and regulatory inspection findings.
Monitor industry trends and evolving regulatory expectations associated with validation and lifecycle management programs.
Promote continuous improvement initiatives that strengthen compliance, inspection readiness, and validation effectiveness.

Required Skills and Abilities

Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
Hands-on experience with the qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation (Experience in at least two of these areas is required)
Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
Strong time-management skills and the ability to organize and coordinate multiple projects at a time
Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
Ability to prioritize tasks and to keep leadership apprised of performance to timelines
Accepts feedback from a variety of sources and constructively manages conflict
Experience in Oral Solid Dose operations and spray drying is preferable
Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

Education and Experience

Bachelor’s degree, preferably in a scientific or engineering discipline. Preference will be given to those with an advanced degree
Minimum of 4 years validation experience required within pharmaceutical industry, with preference given to those with 5-10 years of experience and work history of the following:
Equipment Qualification (IQ/OQ/PQ)
Process Validation
Cleaning Validation
CSV
Validation Risk Based strategies
Validation Lifecycle Management
Risk Assessment Methodologies
PPQ Campaign Support
Technology Transfer

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer
• Prolonged periods of mobility between offices and campus buildings
• Adheres to consistent and predictable in-person attendance