Pharma Manufacturing IT

Pharma Manufacturing IT & OT Architect/Advisor

Worksite location - Somerset, NJ and Morrisville, NC

3 Months +

Senior Pharma/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:

1. Conduct a thorough assessment of the current manufacturing IT and OT infrastructure, including hardware, software, network, controls, and data integrity systems.
2. Evaluate the maturity level of existing IT and OT processes and identify areas for improvement based on industry standards and best practices.
3. Develop a comprehensive strategy and roadmap to enhance the maturity level of manufacturing IT and OT systems, aligning with business objectives and regulatory requirements.
4. Provide expert recommendations on technology solutions, including ERP, MRP, MES, BI/Analytics, and other enterprise applications, to optimize manufacturing operations.
5. Collaborate with cross-functional teams, including IT, operations, quality assurance, and regulatory compliance, to ensure alignment and successful implementation of proposed solutions.
6. Design and implement robust IS and cybersecurity measures to safeguard manufacturing IT and OT systems from potential threats and vulnerabilities.
7. Lead change management initiatives to foster a culture of continuous improvement and innovation in manufacturing IT and OT practices.
8. Provide guidance and mentorship to internal teams on best practices, emerging technologies, and industry trends in pharmaceutical manufacturing IT and OT.

Qualifications:

1. Bachelor's degree in computer science, engineering, or a related field; advanced degree preferred.
2. 10+ years of experience in pharmaceutical or life sciences manufacturing, with a focus on IT and OT systems.
3. In-depth knowledge and hands-on experience with the Purdue model framework and its application in pharmaceutical manufacturing.
4. Proficiency in assessing and optimizing manufacturing IT and OT infrastructure, including network architecture, hardware systems, and software applications.
5. Strong understanding of regulatory requirements, such as FDA regulations (e.g., 21 CFR Part 11), GxP guidelines, and data integrity principles.
6. Demonstrated experience in developing and implementing IT and OT strategies, roadmaps, and plans in a regulated manufacturing environment.
7. Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
8. Relevant certifications, such as CISSP, CISA, or PMP, are a plus.