Manufacturing Shift Leader - Fill Finish & Visual Inspection
We are searching for a passionate and results-oriented leader to oversee our Fill Finish and Visual Inspection operations. In this critical role, you will be responsible for ensuring the production of high-quality products that meet all regulatory requirements and contribute to achieving our operational goals.
What You'll Do:
Lead a team on the production floor, ensuring efficient use of equipment and materials to produce quality products following cGMP guidelines.
Coach, develop, and provide performance feedback to your direct reports.
Foster a safe work environment and ensure adherence to all company policies, EHS standards, and regulatory requirements (cGMP, ISO 6, ISO 7, ISO 8).
Train team members on equipment, processes, and Standard Operating Procedures (SOPs).
Develop and maintain packaging schedules, manage departmental budgets, and participate in project execution.
Conduct investigations, identify root causes of problems, and propose process improvements for enhanced efficiency.
Participate in multi-functional project teams as needed.
Contribute to continuous improvement by reviewing and updating SOPs and other documents.
Perform data analysis using databases, documents, and spreadsheets to support reporting needs.
Oversee final documentation review for compliance and establish clear timelines.
Collaborate with colleagues to ensure smooth product flow and share best practices.
Who You Are:
Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related life science field with at least 5 years of experience (or a Master's degree with at least 2 years of experience).
Prior experience in aseptic processing and supervisory roles is a strong plus.
Experience with PFS manual visual inspection and finished product packaging (ideally with serialization) is preferred.
In-depth knowledge of FDA cGMP regulations is essential.
You possess exceptional communication, leadership, and problem-solving skills.
You have strong technical writing skills and experience in authoring SOPs and deviations.
Proven ability to lead and motivate operational teams.
Demonstrated ability to collaborate effectively in cross-functional settings.
Proficient in MS Office applications.
A passion for leadership and professional development of others.
Experience with current CFRs and a strong understanding of cGMP principles.
