Responsibilities:
- In charge of Process Validation, Equipment IQ and Computer software validation.
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- Adapts machine or equipment design to factory and production conditions.
- May incorporate inspection and test requirements into the production plan.
- Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
Qualifications:
- Bachelor’s degree in Engineering
- Minimum of 2 years of relevant experience.
- Process Validation, Equipment IQ and Computer software validation knowledge.
- Technical writing knowledge and Communication skills
- Experience in Investigation and root cause analysis
- Collaboration and Teamwork with adaptability project tasks requirements.
- Communication skills (English / Spanish)
- Problem-Solving Skill and Continuous Improvement Mindset
- Attention to details
- Shift: 1st shift
Skills Required
- Bachelor's degree in Engineering
- Minimum of 2 years of relevant experience
- Process Validation knowledge
- Equipment IQ knowledge
- Computer software validation knowledge
- Technical writing ability
- Investigation and root cause analysis experience
- Collaboration and teamwork with adaptability
- Communication skills (English/Spanish)
- Problem-solving and continuous improvement mindset
- Attention to detail
- Willingness to work 1st shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
