Senior Computer System Validation Csv Jobs in Virginia

At our company, we aspire to be the premier research‑intensive biopharmaceutical company, using leading‑edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join a purpose‑built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast‑following into production with a focus on quality, safety, and operational excellence. At our site you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

• Lead quality input into the design of the Fastnet non‑sterile, high‑potent small molecule spray drying and drug product manufacturing facility.
• Embed quality expectations in project deliverables from concept through start‑up.
• Review user requirements, design specifications, and related technical documentation for quality impact.
• Support quality risk assessments for facility systems, equipment, utilities, and process flows.
• Ensure design decisions enable contamination control, high‑potent product handling, effective material and personnel flow, and operational robustness.
• Provide quality oversight for commissioning, qualification, and start‑up readiness activities.
• Support change control, deviation assessment, and CAPA development throughout the project lifecycle.
• Partner closely with engineering, operations, validation, EHS, supply chain, project management, technical operations, and quality assurance teams.
• Ensure facility design supports compliance with company standards and applicable FDA, EMA, ICH regulatory requirements.
• Support inspection readiness and the development of complete, accurate, and traceable documentation.
• Respond to health authority inspection questions, write observation responses as needed, and support filing and inspection outcomes.
• Contribute to a smooth transition from project execution to routine manufacturing operations.
• Promote and sustain a strong quality culture across the project team and future site organization.

• Strong background in pharmaceutical quality assurance, quality engineering, or technical operations with 5‑10 years’ experience.
• Experience in spray drying and/or drug product manufacturing, ideally within non‑sterile, high‑potent small molecule operations.
• Experience supporting facility design, capital projects, qualification, or site start‑up activities.
• Expert knowledge of cGMP requirements and global pharmaceutical regulations.
• Strong understanding of contamination control principles, high‑potent material handling, facility segregation and flow design.
• Experience with quality risk management, root‑cause analysis, and scientific problem‑solving.
• Proven ability to work effectively in a matrixed environment and influence, align, and guide stakeholders without direct authority.
• Strong collaboration skills across internal functions and external partners.
• Excellent written and verbal communication skills.
• Strong technical documentation and review capabilities.
• Ability to manage multiple priorities in a dynamic project environment.

Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required. An advanced degree is an advantage.

• Business Management
• Capital Projects
• Change Management
• Chemical Engineering
• Computer System Validation (CSV)
• Contamination Control
• Decision Making
• Driving Continuous Improvement
• GMP Compliance
• GMP Laboratory
• Materials Handling
• People Leadership
• Performance Qualification (PQ)
• Pharmaceutical Quality Control (QC)
• Pharmacy Regulation
• Project Management
• Quality Assurance Engineering
• Quality Auditing
• Quality Control Documentation
• Quality Management Standards
• Quality Management Systems (QMS)
• Quality Risk Assessment
• Quality Risk Management
• Regulatory Compliance

$142,400.00 – $224,100.00 per year, based on qualifications and experience.

Medical, dental, vision, and other insurance benefits for employee and family; retirement benefits including 401(k); paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We are a federal contractor and comply with affirmative action requirements for protected veterans and individuals with disabilities.