Senior Validation Engineer (I, II, III)

Responsibilities

• Generate and develop qualification and validation lifecycle documents, templates, protocols, reports including but not limited to the following: SOPs related to the commissioning, qualification and validation programs, Risk Assessments, System Impact Assessments, Validation Master Plans, URS, project plans, Validation Master Lists
• Review validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systems
• Ensure maintenance of validated status via Periodic Review (PR) and requalification activities
• Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems
• Knowledge of Data Integrity and ALCOA+ principles and the applicability to process and analytical systems
• Knowledge of QC equipment validation as it relates to the interface of IOQ and method validation
• Support vendor qualification activities including risk assessments and participate in selection of vendors that support validation effort
• Support the change control program with respect to facility, equipment, and utility validation changes
• Evaluate validation impact of equipment introduction/upgrades and software/hardware changes
• Follow written SOPs, and ensure SOP training remains current
• Oversee contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, and Equipment
• Provide guidance on topics to foster a quality culture and quality mindset
• Actively participate in continuous improvement activities with cross-functional teams
• Provide status updates to stakeholders and internal customers of validation activities in their respective areas
• Identify qualification/validation gaps, strategize on solutions, drive gap mitigation
• Mentoring and training junior level engineers
• Foster collaborative approach to ensure harmonization of qualification/validation approach across all Cellares sites
• Participate in regulatory inspections

Requirements

• Minimum of a Bachelor's degree in Engineering or a scientific related field and 8 years of experience working in a GMP regulated environment
• Minimum of 5 years qualification and validation hands on experience
• Detail knowledge of 21 CFR Part 210,211, Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) requirements
• Knowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11)
• Excellent technical writing skills with an understanding of good documentation practice
• Self-motivated, detail-oriented and passionate about advancing the field of cell therapies
• Collaborative, solution oriented, comfortable in an agile environment

Benefits

$90,000 - $210,000 a year

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options.