Quality Engineer

Job Title: Quality Engineer

We are currently seeking a Quality Engineer to join the Forge Biologics team. The QE will work as part of a cross functional team providing quality oversight, review and approval of engineering, validation, and quality system deliverables to ensure that products and processes meet the appropriate regulatory agency requirements, internal company standards and current industry best practices.  This includes but may not be limited to validation of computerized systems, commissioning and qualification of GMP equipment and process validation.  The individual chosen for this position will work in close partnership with all operational departments and/or external parties to support GMP manufacturing of drug products.  The focus of this role is to employ site approaches to ensure Forge provides and maintains a state-of-the-art AAV facility for pre-clinical and commercial viral vector products.

Responsibilities:

• Review and approval of validation documents across validation disciplines developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards (Computer System Validation, Commissioning and Qualification, Aseptic Process Simulation, Process Performance Qualification, etc.)
• Use statistical techniques and software to perform Gauge R&R, capability analysis (Cp, Cpk & Ppk), statistical confidence testing, Design of Experiments (DOE), etc.  Utilize Statistical Process Control (SPC) to monitor performance in identifying out of control and potential out of control conditions
• Authoring of computerized system validation scripts for system implementation, maintenance and change control throughout the software development lifecycle (SDLC). Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements.  Translate system requirement specifications into executable validation protocols.
• Initiate/update Risk Assessments on systems and processes. Perform risk analysis and failure prevention using tools such as Failure Modes and Effect Analysis (FMEA).
• As necessary, draft and execute computer system validation documentation (CSV).
• Support Early-stage process validation activities including Technical Transfer and Quality by Design (QBD).  Provide development support for later stage process validation activities such as Process Performance Qualification (PPQ) and Continued Process Verification (CPV).
• Support to quality investigations, continuous improvement (CAPA) and change control by ensuring technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state. 
• Support resolution of issues arising from internal quality assessments/audits, future regulatory inspections, and aid in driving closure of inspection issues
• Support Internal and external audits from a quality engineering and validation perspective.
• Champion and lead continuous improvement efforts
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations, good engineering practice and industry standard procedures.

Requirements

• Bachelor’s Degree in Engineering or related discipline (Chemical Engineering, Biomedical Engineering, Industrial Engineering, Electrical Engineering or Computer Science from a 4-year University)
• 2+ years of experience working in a GMP environment including work in GMP validation disciplines (Process Equipment, Facilities, Utilities, Laboratory equipment, Automation Systems, Computer Systems, Sterilization Processes, Fill Finish Equipment or PPQ) with strong technical knowledge.
• Experience with advanced statistical analysis software or business analytics tools.
• Experience with Software as a Service (SaaS) electronic Quality management system (eQMS)

Preferred

• Previous Biologics or Gene Therapy Experience preferred
• Contract manufacturing Experience preferred
• American Society for Quality (ASQ) or Six Sigma certification

Knowledge, Skills & Abilities:

• Must have strong attention to detail, be organized and proactive. 
• Must have strong technical writing and verbal communication skills.  Employ good document practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
• Project Management abilities to lead projects, meet deadlines, and use critical thinking skills to problem-solve effectively.
• Ability to read and understand engineering drawing documentation such as mechanical layouts and electrical/pneumatic schematics (P&IDs)
• Firm knowledge of Product Development Lifecycle
• Demonstrated experience leading troubleshooting efforts and investigations
• Must have working knowledge of cGMP.  Knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA & EU Data Integrity guidelines, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures