CSV Specialist II

About the Role

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!

The CSV Specialist II is responsible for computerized system validation activities within CRL Manufacturing Operations, including, but not limited to, equipment and software and for assisting in the selection and defining specifications such equipment and software. Responsible for maintaining all documentation pertaining to validation activities. Serve as an information resource for validation team members, contractors, and vendors.

Why Rose BioSolutions

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.
• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.
• Opportunities to grow your technical expertise and take ownership of your work.
• Close interaction with leadership and clients, enabling real influence on project outcomes.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage the full lifecycle of validation projects, ensuring timely delivery, meeting specifications, and maintaining quality throughout.
• Prepare clear and concise validation deliverables for computerized systems, including Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Summary Reports.
• Assist system SMEs in the preparation of test scripts comprising formal testing of functional, system and regulatory requirements in conjunction with computerized system validation. Oversee test script execution.
• Manage multiple validation projects simultaneously, ensuring timely completion and effective communication of project timelines and milestones.
• Adhere to pertinent regulatory requirements and departmental policies and procedures [SOPs, safety procedures and biosafety protocols].
• Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity.
• Collaborate with cross functional teams involved in the validation and maintenance of computerized system (e.g. System Owner, IT, QA, Departmental Managers, vendors, etc.).
• Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
• Identify, schedule and track validation project tasks and timelines using appropriate tools.
• Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
• Schedule validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements.
• Contribute to the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during validation efforts to ensure compliance with applicable regulatory requirements, guidelines, procedures, and policies.
• Proactively identify opportunities for process enhancements and implement innovative solutions to drive efficiency, quality, and effectiveness, fostering a culture of continuous improvement.
• Serve as the primary point of contact for client and regulatory audits related to computer system validation, resolving or mitigating audit findings related to system validation.
• Assist, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation.
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in Computer Science, Information Technology, Engineering, Life Sciences, or related field.
• Experience: 5-7 years of experience in computer system validation within a regulated industry (pharmaceutical, medical device, biotechnology).
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: Certifications like Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training desired.
• Other: Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 11 as they pertain to computerized systems, is preferred.
• Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point, Teams, SharePoint).
• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
• Must regularly communicate with employees/customers; must be able to exchange accurate information.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• The employee may be required to lift and/or move up to 25 pounds and occasionally lift and/or move more than 50 pounds.
• General office working conditions.
• The noise level in the work environment is usually quiet.
• This position may require occasional domestic and international travel.
• May be required to work off-shift or weekends to support validation efforts.

Compensation Data:

The pay rate for this role is $105k – $120k per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.
• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.
• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company contribution.
• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.

Pay: $105,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person