Engineer/Sr. Engineer - Validation
Bionova Scientific LLC Job Description: 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 of protocols for and oversight of Commissioning, SAT, FAT for 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
- Assist 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...
- Understanding of 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
- Operates within GMP quality systems as record owner or subject matter expert including deviations, change control, CAPA, audits and other quality systems.
- Assist 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
- Other activities and duties as required or assigned.
- 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
- Interact 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.
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