Engineer/Sr. Engineer - Validation

Position Summary

Bionova is seeking a motivated and innovative Sr. Validation Engineer to serve in the Facilities and Engineering department. The Sr. Validation Engineer will take a hands-on approach to performing the commissioning and qualification of systems (facilities, utilities, equipment & analytical instruments), processes and/or automation systems and include tasks such as preparing and executing protocols, analyzing test results, and preparing summary reports. As required, this person may also investigate and troubleshoot discrepancies/deviations, propose solutions and manage CAPAs and change control. As part of the F&E team, you will drive cross-functional decisions and influence decisions of user teams as we grow the organization and expand capabilities to meet project goals that ultimately improve patient outcomes.

Essential Duties and Responsibilities

• Oversight of Commissioning, SAT, FAT for utility and process systems
• Creation and execution for development and/or qualification protocols (IQ, OQ, PQ) and summary reports, including data analysis
• Retrieve and compile data from electronic sources/databases and paper records
• Participate in execution of development and/or qualification studies
• Adheres to established regulations and follows cGxP established by site
• Assists in writing and revising other documentation including: Standard Operating Procedures (SOP), User Requirements Specifications (URS), System Impact Assessments (SIA), Validation Master Plan (VMP), Validation Project Plans (VPP), etc…
• Understands GxP documentation and technical writing abilities
• As required, in regulatory submissions and represents qualification during inspections from regulatory agencies and client audits
• As needed, sustains process equipment after construction. Executes (e.g. continuous improvement or NPI) changes to process equipment under QA oversight (GMP compliance)
• Follows GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (operations) requirements
• Assists in GMP compliant detailed design for facility under quality change management and for construction satisfying design intent
• Sustains systems after construction. Executes (e.g. continuous improvement or NPI) changes to systems under QA oversight (GMP compliance)
• Follows GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (operations) requirements

Qualifications

• 5-10 years’ experience performing duties of Process, Utilities, or Facilities Engineer with at least 3-5 years in a GMP manufacturing environment
• Bachelor’s of Science degree in engineering or related science discipline
• Excellent English verbal and written communication skills
• Experience using CMMS systems in cGMP facilities
• Strong technical knowledge of validation principles, Quality Systems, manufacturing, and facility equipment/systems
• Experience with systems such for autoclaves, controlled temperature units, utilities (e.g., WFI, CDA, HVAC), single use bioreactors (SUB), mixers, warehouse, and/or QC instruments (e.g., HPLC, UPLCs)
• Knowledge of current GMP Standards
• Ability to work individually and in a team environment
• Ability to multitask and prioritize tasks
• Interacts well and professionally with diverse group of individuals
• Self-motivated and willing to be proactive in resolving issues
• Flexibility with work hours to meet business needs, including weekends and holidays, as needed
• Experience with MasterControl a plus
• Experience interacting with regulatory agencies to defend Quality Systems
• Comfortable in a fast-paced, collaborative small-company environment, working with minimal direction and able to adjust workload based upon changing priorities

Compensation Range

The base compensation range for this role is between $85,000 and $120,000. However, the actual compensation may vary depending on your experience and qualifications.