Computer Systems Validation Engineer - Ohio, Columbus

The announced job offer is made public by the firm: Forge Biologics and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Ohio at the city Columbus, in the country US - at this current ZipCode: 43085

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Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge's mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, "The Hearth," to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

Position Overview:

We are currently seeking a Computer Systems Validation Engineer to join the Forge Biologics team. The CSV Engineer will be responsible for defining validation requirements, developing systems validation documentation, generating, and executing test protocols, and summarizing validation activities in reports. This individual will play a key role throughout the software development life cycle (SDLC), from validation of completely new systems on projects through qualification of changes for existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of Forges applications and GMP equipment. The individual chosen for this position will work in close partnership with all quality management, automation, IT and operations leadership and/or external parties to support GMP manufacturing of clinical drugs. 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.

Support Automation, IT, Quality, Operations and Engineering teams with oversight and execution of validation and qualification activities for site Computer system, manufacturing, and testing equipment.

Responsibilities:

• Authorship, execution, review, and approval of computer system validation deliverables developed in partnership with functional teams, ensuring the documentation meets regulatory requirements and quality standards
• Assistance in authorship, execution, review and approval of commissioning and qualification deliverables
• Authoring of documents 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.
• Draft and execute validation documentation such as
• Validation Project Plan
• Requirement Specification (URS and FRS)
• Requirement Risk Assessments (RRA)
• System Design and Configuration specifications
• IQ/OQ/PQ Protocols, as necessary
• User acceptance testing (UAT)
• Traceability Matrix (TM)
• Validation summary report
• Server and Host application qualification
• Data Integrity testing
• Provide oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state.

• Support Automation, IT, Quality, Operations and Engineering teams with oversight and execution of validation and qualification activities for site Computer system, manufacturing, and testing equipment.

• Support to quality investigations, continuous improvement and change control by providing technical and validation insight.
• 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, GAMP, 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 (Computer Science, Industrial Engineering, Chemical Engineering, or Electrical Engineering)
• 1+ year(s) of experience working in a Biotechnology, Pharma, Medical Device or other regulated industry.
• Familiarity with automation system communication protocols and automation standards such as ISA 88, 95 and 99
• Experience with Software as a Service (SaaS) enterprise systems such as electronic quality managements systems(eQMS), Enterprise Resource planning (ERP). Laboratory Information Management Systems (LIMS) and Data acquisition/analysis tools.
• Experience with automation systems such as SCADA, DCS, MES, EMS, Asset manager, and BMS systems
• Working knowledge of current good manufacturing practice (cGMP) and CFR Part 210, 211 or 820. Knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures)

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.
• Ability to read and understand engineering drawing documentation such as mechanical layouts, network architecture drawings and electrical/pneumatic schematics (P&IDs)
• Working knowledge of Software Development Lifecycle and Software quality assurance
• Familiarity with automation communication protocols
• Familiarity with various data science and analytics tools
• Familiarity with object-oriented programming languages
• Demonstrated experience leading troubleshooting efforts and investigations