Operational Specialist

Operating Associate/Site Support SME - Filling Discipline

Location: Kenosha, Wisconsin (on-site)

Engagement: 18-month contracting engagement with potential for full-time conversion

Partner: Brooksource Engineering Services supporting a leading pharmaceutical manufacturing partner

Key Objectives / Deliverables:

Role Modeling and Capability Building:

• Serve as a role model, driving habits and capabilities within the process team that align with best practices in manufacturing systems and operational excellence.
• Mentor, coach, and provide feedback to employees to foster a culture of continuous improvement and operational excellence.

Filling Operations Optimization:

• Assess and optimize filling operations to ensure efficiency, accuracy, and compliance with regulatory standards.
• Identify and resolve challenges related to filling processes, including equipment issues and procedural gaps.

Cross-Functional Alignment:

• Collaborate closely with site and cross-functional SMEs to drive alignment and ensure seamless communication.
• Act as a conduit for communication between Process Teams (PTs), Functional Teams (FTs), and Labs.

Batch Process Optimization:

• Identify and resolve batch-related challenges stemming from missing or poorly designed processes.
• Create standard work documents, process maps, and other tools to ensure right-first-time execution and sustainability.

Technical Support and Start-Up Activities:

• Provide technical support to new sites and filling lines during start-up activities.
• Ensure filling operations meet sterility assurance programs and process/product requirements, particularly during early stages of capability building.

Inspection Readiness:

• Support the team in preparing for self-led and/or agency inspections.
• Implement and oversee all aspects of operational readiness, including shop floor readiness and business support processes.

Operational Capability Building:

• Support the site in building the right capabilities for filling operations, including Environmental Monitoring (EM) and Operations shifts.
• Develop and track metrics, review line performances, and address human errors occurring on shift.

Prioritization and Obstacle Removal:

• Assist the site in prioritizing tasks during the start-up of Filling Operations.
• Work with other teams/functions (e.g., Project team, global functions) to remove obstacles and ensure smooth operations.

Resource Planning and Liaison:

• Act as the liaison between the site and RAMP/Acceleration team and other sites for planning support resources.
• Manage and organize environmental monitoring personnel in collaboration with production functions.

Performance Measurement and Compliance:

• Prepare and manage the group's performance measures.
• Ensure practices match procedures in cooperation with the EM supervisor.

Desired Background:

• Education:
• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related field.
• Experience:
• Minimum of 10 years of experience in pharmaceutical manufacturing, with a focus on filling operations and sterility assurance.
• Proven track record in leading and managing cross-functional teams in a manufacturing environment.
• Extensive experience in filling operations, regulatory compliance, and process optimization.
• Skills:
• Strong leadership and mentoring skills, with the ability to drive team performance and foster a culture of continuous improvement.
• Excellent problem-solving skills, with a proactive approach to identifying and resolving process-related challenges.
• Effective communication and collaboration skills, with the ability to work seamlessly with cross-functional teams and external stakeholders.
• In-depth knowledge of regulatory requirements and industry best practices related to filling operations and pharmaceutical manufacturing.
• Certifications:
• Relevant certifications in filling operations, sterility assurance, quality management, or operational excellence are highly desirable.

Other Responsibilities:

• Participate in or drive initiatives or special projects.
• Support a culture of continuous improvement, including cross-functional proposal/assessment and identifying potential actions from events.