Position Summary
Provide technical and operational support to the process development/ improvements/ sustaining efforts in a high volume, multi-product manufacturing environment.
Works with various functions to develop processes for new products and sustain/ improve processes for existing products.
Responsibilities
Operational Support
- Participate in process sustaining, definition, improvement, design, development and quality testing activities in conjunction with Manufacturing, Validation, Supply Chain, Quality Assurance, Facility and Regulatory Affairs.
- Improve process capability, production efficiency and capacity while maintaining and improving quality standards.
- Troubleshoot, performing root cause analysis and provide optimized data-driven solutions for line issues related to yield, quality and throughput in a multi-product manufacturing facility.
- Participate in establishing operating equipment specifications and improvements.
- Analyze process test results, issue reports and makes technical recommendations.
- Construct and execute controlled experiments to address yield and quality is‐sues and drives implementation of solutions in a production environment to meet production goals.
- Serve as a peer-recognized subject matter expertise in at least one area.
Design Engineering
- Work cross functionally with R&D, Manufacturing and Quality to develop cost effective and working production processes for new products and improve processes of existing products.
- Define technical requirements and procedures for manufacturing to process product.
- Evaluate raw material, formulation recipe and process changes, plan and execute associated qualification activities.
Compliance/Training
- Ensure system and process equipment comply with corporate quality system and regulatory requirements.
- Execute training plan across functions.
Leadership
- Lead or support development of key strategic program, complete design and engineering projects within schedule, budget and quality constraints.
- Provides guidance to junior engineers.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Educational Background:
- Bachelor of Science/ Bachelor of Engineering/ Masters or equivalent in Chemical, Biochemical, Biochemistry and/or Bio-technology related field.
Preferred Experiential Background:
- 2- 5 years’ of relevant experience required.
- Work experience in the biotech industries is strongly preferred.
- Experience in a high-tech, high-volume, high-mix consumables manufacturing industry.
- Possess cGMP knowledge. Experience in FDA-regulated environment is a plus.
- Proficiency with chemical processes and analysis.
- Expertise in raw material evaluation, chemical and biological.
- Strong project management skills.
- Excellent organizational skills and attention to detail.
Competencies:
- Manage and/ or facilitate change.
- Good inter-departmental communication skills.
- Good documentation skills and ability to write procedures and training manual.
- Demonstrated ability to work independently.
- Basic troubleshooting skills using computer software.
- Able to apply DOE techniques and Statistical Process Control knowledge.
- Able to analyze data and make logical and rational conclusion.
- Able to perform simple lab work dealing with common chemicals.
