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. **