Senior Engineer 2, CQV

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

The Senior Engineer 2, CQV serves as a subject matter expert and leads the commissioning and qualification of equipment and systems for multiple areas of the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role partners with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.

Requirements

• Bachelor’s degree in Engineering.
• 12 years of experience in validation activities in facilities, commissioning, and systems qualifications.
• Experience with cGMP or working in another highly regulated industry.
• Effective communication, both written and oral.
• Ability to develop effective working relationships internally and externally.
• Ability to effectively present complex information to others.
• Proficient knowledge of Microsoft Office (e.g., Word, PowerPoint).
• Advanced strategic planning and problem-solving skills.
• Knowledge of industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.

Nice To Haves

• Master’s degree in Engineering with 8 years of experience in validation activities in facilities, commissioning, and system qualifications.
• Experience working within industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Experience with Biologics License Application (BLA) submissions etc.

Responsibilities

• Acts as CQV Technical Lead for upstream, downstream or multiple areas to establish validation strategies, develop validation procedures that align with FDB’s Large Scale Biologics platform operating principles and regulatory requirements.
• Provides guidance and leads the management of validation lifecycle for responsible areas for all upstream and downstream mammalian manufacturing processes during Installation Verification (IV), Operational Verification (OV), Installation & Operational Qualification (IOQ), Performance Qualification (PQ) through Good Manufacturing Practices (GMP) release to decommissioning.
• Provides technical support and leads external validation engineers through commissioning, qualification, and validation of Large-Scale Biologics facilities and equipment.
• Participates with FDB’s cross-network to inform and influence strategic management of validation programs, and working knowledge to incorporate global standards at the site level.
• Liaises and collaborates with key stakeholders and support groups (e.g., Manufacturing, Process Science, Automation, Supply Chain, and Quality) to ensure FDB validation requirements are met.
• Collaborates cross-functionally to ensure successful integration of CQV activities into projects.
• Establishes Validation standard operating procedures (SOPs), Validation Project Plan (VPP), Validation Master Plan (VMP), to ensure full cGMP compliance by operations launch.
• Liaises with CQV Document Generation Lead to generate and approve DQ, Design Reviews, SLIA, Test Matrices, Risk Assessments, QA Vendor Assessments, FAT, SAT, CTP, and IOQ Protocols.
• Leads the investigation of qualification deviations or discrepancies utilizing problem solving, and root cause analysis (RCA) to properly identify root causes and develop remediation plans (e.g., corrective and preventive action (CAPAs).
• Performs change control validation assessments to determine risk-based qualification, requirements for new systems, and changes to existing qualified systems.
• Conducts impact and risk assessments to identify risks and develops and leads the implementation of mitigation strategies.
• Provides guidance and training to junior engineers for all CQV-related activities.
• Participates in the Global subject matter expert (SME) Network to ensure cross-site alignment for CQV.
• Prepares presentation packages for FDBN’s Validation Lifecycle program for internal and external audits and client visits and participates in presenting, as required.
• Other duties, as assigned.

Benefits

• Equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior