Building expert teams to advance science.

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!

Reporting to the Manager of Validation, the Validation Engineer II supports the qualification/validation programs for equipment, instruments, facility, cleaning validation/verification and computerized systems used in cellular manufacturing at Rose BioSolutions. As a technical resource for GMP regulated facilities, the Validation Engineer II assists primarily in the development and execution of verification/qualification/validation protocols of cell therapy manufacturing systems, ensuring equipment, computerized systems and facility are operating in compliance with Rose BioSolutions and all applicable regulatory requirements. The Validation Engineer II is expected to work cooperatively with Manufacturing, Facilities, Materials Management, IT, Quality Assurance, and other departments as necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Technical writing and execution of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of basic cell processing equipment such as incubators, centrifuges, freezers, etc.

• Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of lab instruments.

• Technical writing and execution of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of computerized systems used in manufacturing, laboratory and other areas.

• Support the MSAT department in the technical writing of media qualification and process performance qualification (PPQ/PV) protocols as needed.

• Execution of qualification/validation protocols for cell processing equipment, computerized systems, lab instruments, cleaning verification, process validation, shipping/transportation, and other validation activities as needed.

• Schedule validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements.

• Prepare clear and concise validation deliverables for computerized systems, including Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.

• Provide ongoing support for Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies.

• Manage the full lifecycle of validation projects, ensuring timely delivery, meeting specifications, and maintaining quality throughout.

• Proactively identify opportunities for process enhancements and implement innovative solutions to drive efficiency, quality, and effectiveness, fostering a culture of continuous improvement.

• Assist and contribute to the evaluation of non-conformances, exceptions, and/or deviations that could affect product safety and quality.

• Lead validation projects as needed (i.e., smoke studies, etc.)

• Ensure all generated validation documentation meet all applicable regulatory requirements.

• Assist, as needed, during client and regulatory audits related and help resolve or mitigate audit findings related to Validation department.

• Assist in the training of newly hired Validation Associates as needed.

• Provide updates to Manager Validation on validation activities.

• Perform all other related duties as assigned.

QUALIFICATIONS:

• B.S. in related field or a combination of at least 3-5 years of industry experience in cell processing equipment or solid dosage/medical device/biotechnology and facility validation.

• Minimum of 3 years of experience in Equipment, Instrument, Computer System Validation and Facility validation is preferred.

• Minimum of 3 years of experience working in a GxP regulated environment is preferred.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 1, Annex 11, HPRA as they pertain to computerized systems, is required.

• Must demonstrate excellent problem solving ability, technical writing skills, good communication skills, and teamwork.

• Knowledge of manufacturing processes and safety in GMP regulated facilities Pharmaceutical/Medical Device/Biotechnology.

• Knowledge in operating ELLAB and/or the Kaye Validator computerized system and data trace equipment preferred.

• Knowledge of GxP Computerized Systems such as TrackWise®, Maximo® and Metasys® is preferred.

• Efficient in Microsoft® Office and other office software as applicable.

• May be required to work off-shift or weekends to support validation efforts according to business process schedule.

• Must be flexible and able to adapt to company growth and evolving responsibilities.

• Able to wear full cleanroom/protective gowning for ISO 7/5 (Class B and A) cleanrooms and pass gown qualification.

• Ability to multi-task and manage multiple projects with shifting priorities in a fast-paced manufacturing environment

Compensation Data

The pay rate for this role is $85,000-95,000 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.