Job Description
- Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
- Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- 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).
- Familiarity with DCS systems (i.e. Emerson DeltaV, Rockwell SCADA), ERP systems (i.e. SAP or Oracle), and Historians (i.e. OSIsoft PI).
PURPOSE AND SCOPE OF POSITION: The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at the Libertyville site through interaction with internal team members, peer and higher-level customers, as well as external service providers. The individual is responsible for the 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, and computer system validation in support of the vector manufacturing site.
The candidate should have at least 5+ years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing systems development and support.
DUTIES AND RESPONSIBILITIES: - 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 investigation 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, and problems.
- 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: - 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 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 of IT service management platforms to support incident, problem, and change IT operational events (i.e. ServiceNow).
- 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.
- Understanding of computer system validation.
- 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).
Education and Experience: - 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.
- Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.
- 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).
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