Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
The Computer Validation Manager/Sr. Manager will develop, maintain, and improve upon Paragon Computer Software Validation (CSV) strategies by establishing/improving policies and procedures that govern our approach to the overall CSV effort, with the goal of assuring CSV compliance at all company sites.
Key Responsibilities include but are not limited to:
Develop CSV operational strategies by establishing governing policies/procedures.
Generation/oversight of CSV Validation Master Plans for all Paragon manufacturing sites.
Management of CSV projects at both sites, including the oversight of CSV projects and contractors.
Serve as the Validation point of contact for all CSV projects/activities.
Actively participate in the selection process of all new eSolutions introduced at Paragon sites, engaging the projects at an early stage of the process to ensure CSV compliance.
Generation or oversight of CSV protocols for enterprise-level, manufacturing and laboratory systems.
Serve as CSV SME for all client-related issues/concerns dealing with CFR Part 11 compliance and data integrity.
Provide supervision of Paragon CSV Validation Engineers.
Experience & Education:
Bachelor's degree in engineering, science; Master's preferred
10-15 years' experience in a management validation role with responsibility for computer validation
5 years leadership both in developing high performing teams but also leading projects
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications, with a focus on 21 CFR Part 11, 21 CFR Parts 210/211, and GAMP 5.
Knowledgeable of FDA regulations regarding the Validation Life Cycle and the Software Development Life Cycle.
Experience in the validation of cloud base enterprise systems (Enterprise resource planning, LIMS, Doc Management, training, Environmental monitoring systems, and Data Management systems is strongly preferred.
Knowledge of quality business practices and business development.
Excellent multi-tasking, analytical, organizational and leadership skills.
Ability to troubleshoot, identify root cause and systematically resolve problems.
Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.