Key Responsibilities:- Lead and supervise hourly fermentation personnel on 2nd shift including work assignment on-the-floor guidance and performance feedback.
- Conduct start-of-shift and end-of-shift meetings to communicate safety topics production priorities shift handoffs and performance results.
- Partner with the Fermentation Manager to plan and sequence daily and weekly production to achieve unit tank yield quality and uptime goals.
- Coordinate with Engineering Maintenance and other functions to schedule and support preventive and corrective maintenance on bioreactors centrifuges freeze dryers utilities and related equipment.
- Support troubleshooting of equipment and process deviations escalating issues promptly and contributing to root cause analysis and corrective actions.
- Ensure all production cleaning and maintenance records (e.g. batch records logs checklists) are completed accurately in real time and in compliance with internal and regulatory requirements.
- Maintain staffing and attendance oversight for the shift to ensure adequate coverage and continuity of operations.
- Collaborate closely with the 1st Shift Supervisor and other shifts to ensure clear handoffs alignment on open work and consistent application of procedures.
- Contribute to the creation review and revision of SOPs and work instructions for fermentation operations.
- Promote a culture of safety quality and continuous improvement through daily behavior coaching and participation in initiatives.
Additional Responsibilities:- Support onboarding training and cross-training of fermentation personnel on processes equipment safety and documentation requirements.
- Assist in reviewing production and performance data (e.g. yields deviations downtime) and recommend improvements in processes methods or equipment.
- Help maintain and update electronic tools (e.g. Excel SharePoint Fermentation Formula Masters) used by the fermentation team and on the production floor.
- Participate in internal or external audits inspections and investigations as requested.
Typical Work Environment:- Manufacturing plant environment with exposure to noise non-temperature-controlled areas dust fumes odors and biological materials.
- Routine work around bacteria enzymes chemicals and process utilities with strict adherence to hygiene and safety protocols.
Minimum Qualifications:Education & Training:- High school diploma or equivalent required.
- Additional training or coursework in fermentation microbiology bio-manufacturing or a related discipline preferred.
Relevant Experience:- 1 year of experience in fermentation bio-manufacturing or a related regulated production environment preferred.
- Experience leading coordinating or mentoring others in a manufacturing setting strongly preferred.
- Experience working under GMP HACCP FSMA or similar quality and food safety systems.
Technical Skills:- Working knowledge of GMP standards QA/QC principles and basic root-cause problem solving.
- Familiarity with inventory management including FIFO practices.
- Proficiency with basic computer applications (e.g. email Excel SharePoint production or quality systems).
- Ability to perform basic math and interpret process parameters trends and production documentation.
Non-Technical Skills (Core Competencies):- Leadership & Communication: Clearly communicates expectations provides constructive feedback and manages conflict professionally.
- Continuous Improvement: Identifies opportunities to improve safety quality efficiency and reliability and helps implement solutions.
- Collaboration: Works effectively across shifts and functions (e.g. Quality Maintenance Engineering Supply Chain) in a global organization.
- Results Orientation: Demonstrates dependability strong follow-through and effective prioritization to meet production targets and deadlines.
- Attention to Detail & Organization: Maintains accurate records organizes work effectively and operates with minimal supervision.
Licenses/Certifications:- Forklift certification (or ability to obtain within a defined timeframe).
Physical Requirements:- Ability to lift up to 50 pounds periodically.
- Frequent standing walking bending and movement throughout the facility.
- Ability to work in proximity to chemicals enzymes and biological materials while wearing required PPE.
Safety Requirements:- Follow all company safety procedures GMP HACCP FSMA OSHA and site-specific safety rules at all times.
- Consistently and correctly use required Personal Protective Equipment (PPE).
- Immediately report unsafe conditions near misses and incidents and actively participate in safety and food safety improvements.
- Adherence to all food safety procedures as per FDA regulations including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal state or local food safety regulations.
Required Experience:
Manager
Key Responsibilities:Lead and supervise hourly fermentation personnel on 2nd shift including work assignment on-the-floor guidance and performance feedback. Conduct start-of-shift and end-of-shift meetings to communicate safety topics production priorities shift handoffs and performance results. Par...
Key Responsibilities:- Lead and supervise hourly fermentation personnel on 2nd shift including work assignment on-the-floor guidance and performance feedback.
- Conduct start-of-shift and end-of-shift meetings to communicate safety topics production priorities shift handoffs and performance results.
- Partner with the Fermentation Manager to plan and sequence daily and weekly production to achieve unit tank yield quality and uptime goals.
- Coordinate with Engineering Maintenance and other functions to schedule and support preventive and corrective maintenance on bioreactors centrifuges freeze dryers utilities and related equipment.
- Support troubleshooting of equipment and process deviations escalating issues promptly and contributing to root cause analysis and corrective actions.
- Ensure all production cleaning and maintenance records (e.g. batch records logs checklists) are completed accurately in real time and in compliance with internal and regulatory requirements.
- Maintain staffing and attendance oversight for the shift to ensure adequate coverage and continuity of operations.
- Collaborate closely with the 1st Shift Supervisor and other shifts to ensure clear handoffs alignment on open work and consistent application of procedures.
- Contribute to the creation review and revision of SOPs and work instructions for fermentation operations.
- Promote a culture of safety quality and continuous improvement through daily behavior coaching and participation in initiatives.
Additional Responsibilities:- Support onboarding training and cross-training of fermentation personnel on processes equipment safety and documentation requirements.
- Assist in reviewing production and performance data (e.g. yields deviations downtime) and recommend improvements in processes methods or equipment.
- Help maintain and update electronic tools (e.g. Excel SharePoint Fermentation Formula Masters) used by the fermentation team and on the production floor.
- Participate in internal or external audits inspections and investigations as requested.
Typical Work Environment:- Manufacturing plant environment with exposure to noise non-temperature-controlled areas dust fumes odors and biological materials.
- Routine work around bacteria enzymes chemicals and process utilities with strict adherence to hygiene and safety protocols.
Minimum Qualifications:Education & Training:- High school diploma or equivalent required.
- Additional training or coursework in fermentation microbiology bio-manufacturing or a related discipline preferred.
Relevant Experience:- 1 year of experience in fermentation bio-manufacturing or a related regulated production environment preferred.
- Experience leading coordinating or mentoring others in a manufacturing setting strongly preferred.
- Experience working under GMP HACCP FSMA or similar quality and food safety systems.
Technical Skills:- Working knowledge of GMP standards QA/QC principles and basic root-cause problem solving.
- Familiarity with inventory management including FIFO practices.
- Proficiency with basic computer applications (e.g. email Excel SharePoint production or quality systems).
- Ability to perform basic math and interpret process parameters trends and production documentation.
Non-Technical Skills (Core Competencies):- Leadership & Communication: Clearly communicates expectations provides constructive feedback and manages conflict professionally.
- Continuous Improvement: Identifies opportunities to improve safety quality efficiency and reliability and helps implement solutions.
- Collaboration: Works effectively across shifts and functions (e.g. Quality Maintenance Engineering Supply Chain) in a global organization.
- Results Orientation: Demonstrates dependability strong follow-through and effective prioritization to meet production targets and deadlines.
- Attention to Detail & Organization: Maintains accurate records organizes work effectively and operates with minimal supervision.
Licenses/Certifications:- Forklift certification (or ability to obtain within a defined timeframe).
Physical Requirements:- Ability to lift up to 50 pounds periodically.
- Frequent standing walking bending and movement throughout the facility.
- Ability to work in proximity to chemicals enzymes and biological materials while wearing required PPE.
Safety Requirements:- Follow all company safety procedures GMP HACCP FSMA OSHA and site-specific safety rules at all times.
- Consistently and correctly use required Personal Protective Equipment (PPE).
- Immediately report unsafe conditions near misses and incidents and actively participate in safety and food safety improvements.
- Adherence to all food safety procedures as per FDA regulations including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal state or local food safety regulations.
Required Experience:
Manager
View more
View less