Aseptic Filling Operations Lead

Job Title: Aseptic Filling Operations Lead

Location: Raleigh, NC

Job Type: Contract to Hire

Job Description:

The Filling Operations Associate will play a crucial role in the successful startup, ramp-up, and ongoing operations of Parenteral Filling areas. This position is designed for an individual who is committed to operational excellence, continuous improvement, and ensuring that filling operations are conducted with the highest standards of safety, quality, and efficiency. The role involves supporting the site's readiness for routine production, troubleshooting and resolving batch challenges, and fostering a culture of continuous improvement.

Key Responsibilities:
Leadership & Process Improvement: Serve as a role model and drive effective habits and capabilities in the process team, ensuring adherence to the Manufacturing Standard Operating Environment (MSOE) principles and maintaining high standards of operational excellence.
Batch Issue Resolution: Identify and resolve batch-related challenges, particularly those arising from missing or poorly designed processes. Proactively address and troubleshoot issues to ensure right-first-time execution.
Documentation & Tools Creation: Develop and maintain standard work documents, process maps, and other operational tools to support right-first-time execution, sustainability, and continuous improvement across the filling processes.
Consultation on Best Practices: Provide guidance and best practice recommendations for work orders, deviations, change controls, and other key processes. Assist teams in adhering to best practices to enhance operational efficiency and compliance.
Operational Readiness: Support the Filling Process Team in the implementation and oversight of all aspects of operational readiness, ensuring that shop floor processes are fully prepared for routine production. Assist with the transition from APS to routine production, ensuring readiness approximately 9 months after PV (Process Validation).
Capability Building: Support the site in developing and building the right capabilities for operations, particularly for shift and process teams. Foster a learning culture and ensure the team is well-prepared to manage routine production.
Ramp-Up Support: Assist with the ramp-up process by establishing appropriate metrics, reviewing line performance, and addressing human errors that may occur on shift. Support the team in prioritizing critical tasks during the startup phase.
Obstacle Removal & Cross-Functional Collaboration: Work with other teams/functions (e.g., Project Team, GPP) to remove operational obstacles and ensure that the site is progressing toward ramp-up and full production. Foster a collaborative and problem-solving environment.
Liaison with Central Functions and Project Teams: Serve as the point of contact for central functions and project teams, ensuring alignment on plans, sharing of best practices, and escalation of issues as needed.
RAMP/Acceleration Team Liaison: Act as the liaison between the site and the RAMP/Acceleration team, coordinating the planning of support resources and ensuring alignment on startup and ramp-up activities.
Initiatives & Special Projects: Participate in or lead initiatives or special projects aimed at improving operational efficiency, safety, and quality in the filling area.
Continuous Improvement Culture: Champion a culture of continuous improvement by contributing to cross-functional efforts to assess, propose, and implement process improvements. Encourage collaboration across departments to drive positive changes.

Qualifications:
Education: Bachelor's degree in Life Sciences, Engineering, Manufacturing, or a related field. Certifications in Quality Control, Operations Management, or Lean/Six Sigma are preferred.
Experience: Minimum of 2-4 years of experience in pharmaceutical or biotechnology operations, with a focus on filling operations or manufacturing. Experience with Parenteral operations is highly desirable.
Skills:
Strong problem-solving skills, particularly in identifying and addressing batch-related challenges and process inefficiencies.
Proficiency in creating and maintaining standard work documents, process maps, and operational tools.
Familiarity with GMP (Good Manufacturing Practice) requirements and operational readiness processes.
Experience with ramp-up and startup operations, particularly in a Parenteral or aseptic manufacturing environment.
Excellent communication and collaboration skills, with the ability to work cross-functionally and influence teams toward common goals.
Ability to mentor and support team members in building the necessary operational capabilities.
Knowledge of continuous improvement methodologies (e.g., Lean, Six Sigma) and how to apply them in a manufacturing environment.

Job Type: Contract

Pay: $70.00 - $80.00 per hour

Expected hours: 40 per week

Schedule:
8 hour shift
Monday to Friday

Application Question(s):
Are you located in Raleigh, NC?
What is your ideal pay rate?

Ability to Commute:
Raleigh, NC 27617 (Required)

Ability to Relocate:
Raleigh, NC 27617: Relocate before starting work (Required)

Work Location: In person