Softworld, Inc. Information Technology Services
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Job Title: Pharma Manufacturing IT & OT Architect/Advisor
Job Location: Hybrid, Somerset, NJ and Morrisville, NC, and other potential sites later
Travel details - Hybrid - will need to travel 1-2 times a month.
Onsite Requirements:
Job Description:
Key Responsibilities:
Qualifications:
** 3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply. **
Pharma Manufacturing IT & OT Architect/Advisor
Posted: 05/13/2024
2024-05-13
2024-06-19
Employment Type:
Contract
Industry: IT
Job Number: BBBH76626_1715639042
Pay Rate: Up to US$0.00 per year
Job Description
Job Title: Pharma Manufacturing IT & OT Architect/Advisor
Job Location: Hybrid, Somerset, NJ and Morrisville, NC, and other potential sites later
Travel details - Hybrid - will need to travel 1-2 times a month.
Onsite Requirements:
- Maturity model assessment
- Knowledge and experience around Pharma or Life Sciences IT/OT architecture including network & infrastructure, security& controls, data integrity, and enterprise applications (ERP, MRP, MES, BI/Analytics, etc.)
- Excellent verbal and written communication skills and ability document current state-future state findings and solution recommendations, strategies, planning, etc.
Job Description:
- SeniorPharma/Life Sciences Manufacturing IT and OT Consultant to assess, analyze, and strategize the current state of IT and OT infrastructure and processes within our pharmaceutical manufacturing facilities.
- The consultant will play a pivotal role in evaluating the maturity level of existing systems, recommending improvements, and devising a comprehensive vision, strategy, roadmap, and implementation plan to enhance our manufacturing IT and OT landscape.
- Must have extensive experience in the pharmaceutical or life sciences industry, a deep understanding of the Purdue model framework, and proficiency in various manufacturing IT and OT technologies and applications.
Key Responsibilities:
- Conduct a thorough assessment of the current manufacturing IT and OT infrastructure, including hardware, software, network, controls, and data integrity systems.
- Evaluate the maturity level of existing IT and OT processes and identify areas for improvement based on industry standards and best practices.
- Develop a comprehensive strategy and roadmap to enhance the maturity level of manufacturing IT and OT systems, aligning with business objectives and regulatory requirements.
- Provide expert recommendations on technology solutions, including ERP, MRP, MES, BI/Analytics, and other enterprise applications, to optimize manufacturing operations.
- Collaborate with cross-functional teams, including IT, operations, quality assurance, and regulatory compliance, to ensure alignment and successful implementation of proposed solutions.
- Design and implement robust IS and cybersecurity measures to safeguard manufacturing IT and OT systems from potential threats and vulnerabilities.
- Lead change management initiatives to foster a culture of continuous improvement and innovation in manufacturing IT and OT practices.
- Provide guidance and mentorship to internal teams on best practices, emerging technologies, and industry trends in pharmaceutical manufacturing IT and OT.
Qualifications:
- Bachelor's degree in computer science, engineering, or a related field;advanced degree preferred.
- 10+ years of experience in pharmaceutical or life sciences manufacturing, with a focus on IT and OT systems.
- In-depth knowledge and hands-on experience with the Purdue model framework and its application in pharmaceutical manufacturing.
- Proficiency in assessing and optimizing manufacturing IT and OT infrastructure, including network architecture, hardware systems, and software applications.
- Strong understanding of regulatory requirements, such as FDA regulations (e.G., 21 CFR Part 11), GxP guidelines, and data integrity principles.
- Demonstrated experience in developing and implementing IT and OT strategies, roadmaps, and plans in a regulated manufacturing environment.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
- Relevant certifications, such as CISSP, CISA, or PMP, are a plus.
** 3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply. **
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