Summary:
In this hands-on position, the employee is responsible for performing and leading manufacturing activities in a cGMP environment. The scope of the position includes writing and revising SOPs, Production Batch Records (PBRs), Forms and validation documents. This individual will train Manufacturing Technicians to perform work in a safe, accurate and timely manner, assuring cGMP compliance. Duties also include assisting with the development of processes, specifications, validation protocols and other validation and engineering related documentation. May also perform routine preventive maintenance activities and manage validation and revalidation projects.
Essential Duties:
- Lead activities to manufacture sterile nasal spray products in a cGMP environment.
- Organize, prioritize and execute manufacturing activities for assigned shift, including process and cleaning validation to support commercial cGMP manufacturing.
- Implement, optimize, and troubleshoot manufacturing processes and equipment.
- Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.
- Ensure facility is opened prior to the start of the shift and secured at the end of the shift.
- Provide leadership during the off-shift to all site personnel.
- Provide communication regarding the status and output of each unit operation for responsible shift.
- Coach team members and provide developmental feedback.
- Deliver results for safety, quality, waste reduction, and operational excellence.
- Complete PBRs, Logbooks, Forms, and other documentation.
- Assist in compilation and review of lot records prior to submission to QA.
- Write and review SOPs and Forms to accurately reflect the current procedures.
- Maintain an inventory of supplies necessary for manufacturing.
- Maintain the manufacturing area in a neat and clean manner.
- Assist or conduct investigations to resolve incidents and deviations.
- Coordinate manufacturing, calibration, and maintenance activities with other departments.
- Write, execute and review validation protocols for manufacturing support equipment.
- Independently champion manufacturing or facility related improvement projects.
- Participate in the performance of routine preventive maintenance on facilities and equipment.
- Help identify continuous improvement and cost savings opportunities.
- Lead investigations related to manufacturing deviations and assure thoroughness of investigation, identification of root cause, documentation and closure.
- Other duties as assigned.
Qualifications:
- BS in a scientific discipline or equivalent experience.
- 3 - 5 years of applicable experience working in a pharmaceutical manufacturing environment including hands-on manufacturing or validation experience.
- Experience with sterilization processes or aseptic technique preferred.
- Hands on experience in equipment troubleshooting and repair.
- Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, and pharmaceutical processing and plant equipment.
- Motivated to perform work while maintaining a focus on the long-term learning and self improvement.
- Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
- Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
- Good written communication skills to write SOPs and other cGMP documents.
- Excellent organizational skills and attention to detail.
- Strong leadership and interpersonal skills and the ability to work well in a team environment.
- Experienced with Microsoft Word and Excel.
- Qualified to work with controlled substances.
