Biotech Process Development Jobs in Indiana (NOW HIRING)

POSITION PURPOSE                                                                    

The Plant Hygienist provides the technical expertise and leadership to establish and maintain procedures for manufacturing, safe products including cGMP, machine design, cleaning & sanitization.  The incumbent is responsible for working with the equipment preparation & set up.  The Plant Hygienist provides leadership on the resolution of hygiene/hygienic issues and on preventative measures.  This position utilizes knowledge of microbiology, manufacturing

plant hygiene and related sciences to ensure that the environment, equipment, materials and processes all are microbiologically acceptable. 

The Plant Hygienist interacts primarily with, but not limited to, the following departments: Operations, Quality Assurance, Quality Control, Quality Systems, Maintenance, Warehouse, R&D, Training, Purchasing, Customer Service, and the New York & Jonesboro Nice Pak Sites.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Responsible for benchmarking best practices for cleaning and sanitization to highlight and implement best practices across the manufacturing site.
• Work with the Quality, Engineering, Operations, and Maintenance to develop and implement an effective preventative maintenance program for equipment.
• Review & evaluate procedures regularly for their effectiveness in mitigating microbiological contamination risk.  Revise as required for continual improvement.
• Work with the Microbiology Laboratory to train all operations personnel on cGMP procedures and strategies to minimize the introduction of microorganisms into the environment and manufacturing processes.
• Works with the Microbiology Laboratory to identify swabbing/sampling locations of equipment, water testing points of use, raw material sampling, finished product sampling, compressed air sampling and room air sampling.
• Display leadership in Good Manufacturing Practices on the production floor.
• Provide annual training to ensure that all employees are aware of their individual responsibilities in maintaining a clean & sanitary production environment.
• Responsible for guidance and leadership in conducting manufacturing assessments related to the cleaning and sanitization procedures, sanitary design of equipment and overall environmental hygiene.
• Evaluate and approve cleaning accessories and disinfectants used in sanitation procedures.
• Audit cleaning systems, procedures and validations regularly.  Recommend corrective action(s) for unsanitary conditions identified.
• Plan and coordinate periodic plant walkthroughs and implement improved practices based upon observations.
• Provide leadership during audits (internal, external and customer) and provide assistance in rectifying identified issues/observations.
• Provide technical expertise and assistance in the Design/Development of testing protocols and validation studies.
• Support audits (external & customer).
• Support internal audits in the planning, execution, documentation and follow up to ensure timely closure and address any identified compliance gaps, trends or recurring issues. 

SUPPORT MICROBIOLOGY LAB

• Work closely with the Microbiology Laboratory to share information, testing results and any remedial activities required.
• Participate in investigations involving the microbiological testing of finished goods & raw materials.
• Assist in the creation, implementation, and administration of Microbiology based programs (training, gowning, etc.)

• Publish metrics of environmental trends, issues and preventative measures.

PERFORMANCE MEASUREMENTS

1. Annual Goals & Objectives
2. Quality Compliance
3. Cleaning Validation Reports
4. Cleaning/Sanitization Improvements
5. Training Maintenance
6. Service and Communication
7. Technical Expertise in Subject Matter

LI-KM1

EDUCATION/CERTIFICATION:

Bachelor’s degree in Biology and/or Microbiology, other related science degree with a strong Microbiology background

REQUIRED KNOWLEDGE:

• Understanding and knowledge of the manufacturing equipment design and maintenance, environmental monitoring programs, cleaning & sanitization processes and validations.
• Knowledge of positive pressure HEPA filtered air systems, HVAC systems and pharmaceutical water systems.
• Basic knowledge of sterilization science.
• General knowledge of biotech process, equipment and their microbiological control.

EXPERIENCE REQUIRED:

• A minimum of four (4) to seven (7) years’ experience within cosmetics or pharmaceuticals manufacturing environment regulated by 21CFR210/211 with a concentration in microbiology.
• Familiarity with ISO, FDA, USP guidelines and regulations regarding environmental monitoring and utility systems.
• Experience in collaborating with various functional roles within the organization to develop strategies and execute action plans to resolve critical issues.

SKILLS/ABILITIES:

• Strong presentation and communication (written and verbal) skills in the presence of varying levels of the organizational hierarchy. 
• Strong analytical/problem-solving skills with the ability to conduct root cause analysis for out-of-specification/out-of-trend results. 
• Understanding of quality systems, change control, corrective action/preventive action, process/product qualification, and the successful application of these strategies across an organization to produce desired results.
• Demonstrated ability in deviation investigations, analyzing and interpreting hygiene issues and identifying practical preventive solutions.
• Knowledge and application of continuous quality improvement tools and metrics to cost effectively improve product quality, safety and plant hygiene standards.
• Strong inter-personnel skills, acts with integrity, executes with discipline and possesses strong motivational and team building skills.
• Ability to manage time efficiently.
• Skilled in statistical data interpretation including microbial identification.

WORKING CONDITIONS

NONE:

No hazardous or significantly unpleasant conditions.