Joseph Steimle

• Monitored and controlled manufacturing processes and facilities in accordance with current good manufacturing practices to ensure operational integrity.
• Supported the implementation of new procedures or systems within the facility, adapting quickly to changes while maintaining high-quality output levels consistently.
• Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
• Trained new production staff members on safe and efficient production procedures and proper machine operations.
• Performed equipment maintenance and calibrations to drive accurate measurements and production of quality products.
• Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
• Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.
• Is proficient on processes and equipment and serves as a hands-on resource in Production
• Conducts all assigned activities in a safe and cGMP compliant manner
• Tasks include, but are not limited to:

-Cleaning, preparing, and sterilizing production equipment

-Cleaning and disinfecting production rooms

-Assembly, set-up, and disassembly of production equipment

-Executing process steps according to defined SOPs and BPRs

-Documenting activities in accordance with cGMPs

• Handling biologically and chemically hazardous goods
• Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP)
• Supporting projects of medium scope (e.g Operational Excellence, Safety)
• Revising SOPs and BPRs
• Supporting Qualification and Validation activities
• Qualified trainer on tasks and equipment
• Recognizing and trouble shooting process issues and initiating deviations with oversight
• Supports the collection and tracking of area metrics and process control data
• Supports investigator in root cause investigations and CAPA completion for level 1 deviations
• Supports a high performance teamwork environment and demonstrates Seqirus Values and behavior's
• Escalated manufacturing issues to management and quality assurance to identify solutions.
• Delivered manufacturing requirements and attained production schedule to properly plan, forecast and meet demand.
• Conducted regular inspections to identify and resolve equipment issues proactively.

• Directed daily activities of 10 technicians, optimizing processes in bulk amino acid manufacturing.

•Supervision (hands on operations, if needed), cleaning and sanitation of facilities.

•Team leads of 5s six sigma orientation and start-up.

•Writing and knowledge of SOP’s deviations and batch production records.

• Facilitated training sessions on fermentation, mains filtration, and chromatography operations.

•Cell Culture operations, bioreactors, centrifuges, and evaporators.

•Mentor new operators and train them in GMP operations.

•Writing of SOP’s and Batch Records.

•Writing of Deviations and CAPA’s.

•Conduct daily team meetings and safety walk through.

• Led cross-functional teams in problem-solving initiatives, fostering collaboration across departments.
• Analyzed operational data to drive strategic decisions and improve overall efficiency.
• Resolved conflicts among team members promptly, maintaining a harmonious working environment conducive to productivity.
• Enhanced communication within the team by holding regular meetings and encouraging open dialogue among all members.
• Reduced employee turnover by fostering a positive work environment and providing ongoing feedback to staff members.

• Completed the scheduling of all produce employees
• Trained and coached new team members.
• Planned attractive displays, replenishing purchased items to maintain eye-catching appearance.
• Maintained comprehensive compliance with workplace and food safety standards to protect staff and customers.
• Maintained appropriate inventory levels and completed vendor orders when necessary
• Worked towards keeping a high level of cleanliness at all times
• Ensured product rotation to keep loss at a minimum
• Provided strong customer service.