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.