Computer Systems Validation Engineer

Job Description:

• The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers.
• The individual is responsible for development of and adherence to system governance procedures.
• The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity.
• Reporting into the site Digital Plant organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management, computer system validation in support of the vector manufacturing site.
• Support the IT Quality & Compliance for the Cell Therapy Vector manufacturing site.
• Take ownership of deviations, CAPAs and investigations involving the Manufacturing IT Systems.
• Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements.
• Engage technical experts as needed to author and present change requests and author investigations write-ups.
• Support Health Authority and internal audits.
• Collaborate and support the other Site IT groups (Manufacturing IT Systems & MES, Operational Technology Systems & Automation, Enterprise Systems and Integration, IT Site Shared Services) to ensure we can correctly support the manufacturing site.
• Gain proficiency in the IT Service Management platform ServiceNow to create and track service requests, incidents, requests, problems, etc.
• Provide support for operationalizing the manufacturing and peripheral systems.
• Responsible for Computer System Validation of local/site-based systems
• Accountable for the continued compliance of IT systems, procedures and training for vector manufacturing and lab systems.

Qualifications :

• Bachelor's degree in an engineering or MIS discipline.
• Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
• At least 5+ years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines.
• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication
• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Familiarity with MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV, ERP systems (i.e. SAP or Oracle), EBRs (i.e. InfoBatch) and Historians (i.e. OSIsoft PI).
• Understanding of computer system validation (CSV).
• Experience in configuring, troubleshooting and setting it up to communicate with the network.
• Knowledge and experience in utilizing Change Management Applications i.e. ServiceNow, Infinity, Veeva, Valgenesis
• Experience in leading investigations and initiating deviations and Change Control activities.
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity).
• Understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing systems development and support.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.