(Archived) Manufacturing Technical Coordintor - Pharmaceutical

Position Summary

The Manufacturing Technical Coordinator will assist with leading daily departmental operations, provide specialized technical expertise and leadership including equipment / process knowledge to assist various groups such as Automation and Reliability Engineering, Maintenance, Procurement, GMT, and VMRD in the key functions associated with the production of Pharmaceutical products.

Position Responsibilities

• Assist area leads in daily operations and leadership of departmental colleagues. Utilize advance knowledge and demonstrated specialized skills to operate complex processes and equipment in the department.
• Oversee production when Team Leader is unavailable. Provide solutions to production issues that may arise when Team Leader is unavailable. Support / lead initiatives to Improve the Business in the area.
• Work with the technicians to develop long range schedules.
• Assist in the development of departmental colleagues.
• Evaluate and develop recommendations in the design or redesign of equipment and processes.
• Assist with production process transfers, including Regulatory Compliance, Process Validation requirements, and process and equipment designs.
• Assist with implementation of process changes required to support the site Cost Improvement Program.
• Lead specialized projects identified and prioritized by Management and GMT. Recommend equipment and process enhancements to provide improved efficiencies, safety, and competitive advantages.
• Maintain competence on technological developments.
• Coordinate execution of special projects that enhance productivity of the area.
• Conduct specialized training and coaching for OTE, including trouble shooting. Should include weigh activities, blenders, granulators, fluid bed driers, high shear mixers, milling and screening, compression (tableting), and tablet coating processes.
• Develop and revise SOPs and Job Training Checklists for specialized training.
• Significant amount of time spent on special projects
• Key focus will be dry compounding and compression (tableting).

Education and Experience

REQUIRED JOB RELATED CANDIDATE QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS)

• Ten years manufacturing experience in Pharmaceutical Manufacturing with emphasis on dry compounding and tableting.
• RFT Method 1 training and experience preferred.
• Broad understanding of Pharmaceutical operations (weigh, granulation, coating, and compression).
• In depth knowledge of facility and facility specific procedures.
• Experience in special projects (CIPs, product transfers, investigations, and validations) that have direct impact on the department’s success.
• Demonstrated understanding of SOPs and cGMPs

Knowledge of FDA, DEA, OSHA regulations.

Technical Skills and Competencies Required

• Effective communication skills both written and oral.
• Demonstrated ability to interact with and positively influence internal and external work groups.
• Expertise in metric system and math.
• Working knowledge of scientific methods.
• Requires occasional supervision from the Team Leader or Technical Specialist while working toward a definitive objective using a wide range of procedures.
• Plans and arranges own work with little oversight required.
• Skilled in analyzing complex issues. Possesses innovative thinking and the ability to define problems, develop alternative courses of action, and drive effective solutions.
• Experience utilizing RFT tools and methods.
• Demonstrated good listening skills.
• Demonstrated ability to work in a team environment.
• Demonstrated positive attitude.
• Demonstrated respect for co-workers