Capital Projects Compliance Expert

Job Overview:

As a key team member, you will partner with stakeholders to develop and implement compliance strategies for capital projects.

You will lead the development of validation plans and drive consistent practices across sites and programs. Your expertise in computer system validation will ensure regulatory and quality requirements are met while promoting a risk-based approach.

• Lead validation activities for digital manufacturing division capital projects, ensuring alignment with industry standards and regulations.
• Develop and drive CSV strategy and approaches across capital projects in the region, fostering collaboration between teams.
• Ensure compliance with quality management systems, systems development life cycle, cybersecurity, and data integrity principles.
• Act as subject-matter expert and primary liaison with product and technology teams for computer system validation in capital projects, providing guidance on best practices.
• Recruit, develop, and coordinate internal and external CSV resources for program needs, driving talent acquisition and retention.
• Support the development and maintenance of validation templates and standards in electronic validation systems.
• Provide training, coaching, and ongoing validation support to project and site teams, enhancing their skills and knowledge.
• Coordinate with site compliance/validation, digital teams, quality functions, and other stakeholders to align activities, facilitating effective communication.
• Drive adoption of automation validation standards and validate automation systems and MES integrations, ensuring seamless integration.
• Identify IT/OT compliance risks, lead remediation activities, and execute risk assessments for new or changed technologies, mitigating potential threats.
• Support audit responses and work with local quality organizations on compliance strategies, ensuring regulatory compliance.
• Report trends and challenges in procedural adherence and champion relevant updates to SDLC policies and procedures, driving process improvement.
• Participate in compliance communities to share learnings and improve execution across the division, fostering a culture of excellence.

• Bachelor's degree in Computer Science, Engineering, Regulatory Compliance, or related field.
• 8+ years supporting compliance and validation activities in capital projects, with a strong track record of delivering results.
• Strong experience with systems used in digital manufacturing projects, including automation, MES, and real-time integration.
• Deep knowledge of systems development life cycle (SDLC), quality management systems, and computerized systems validation.
• Familiarity with relevant regulations for computerized systems validation and compliance, with a focus on quality and safety.
• Working knowledge of ISA-95 and ISA-88 standards in a regulated environment, ensuring compliance with industry best practices.
• Experience validating cloud, Software-as-a-Service, analytics, and data integration platforms, with a focus on security and reliability.
• Proven ability to design and implement validation plans and strategies, with a focus on risk mitigation and compliance.
• Experience with automation systems (DCS, PLC/SCADA) and leading validation teams, with a focus on efficiency and effectiveness.
• Good understanding of end-to-end manufacturing processes, including manufacturing, quality, and supply chain.
• Strong project management, stakeholder engagement, and communication skills, with the ability to explain complex topics clearly to diverse audiences.
• Strategic thinker who can work with ambiguity, prioritize, and deliver results independently, with a focus on innovation and improvement.

Preferred Qualifications:

• Prior experience in the pharmaceutical or life sciences sector, especially in manufacturing, supply chain, or quality.
• Experience integrating shopfloor and laboratory systems at enterprise scale with resilience and performance considerations.
• Background in manufacturing analytics, process modeling, or advanced data analysis, with a focus on data-driven decision-making.
• Familiarity with business process reengineering and application development methodologies, with a focus on agility and adaptability.