Responsibilities:
- 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
- 3+ years of relevant experience.
- Process Validation, Equipment IQ and Computer software validation knowledge
- Technical writing knowledge and Communication skills
- Investigation and root cause analysis skills
- Must have knowledge in Process Validation, Equipment IQ and Computer software validation.
- Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (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).
- Knowledgeable on statistical techniques.
- In addition, the resource needs to be schedule oriented in order to meet projects objectives and assignments without impacting deadlines and it is really important for the resource to have good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team.
- Shift: 1st shift
Skills Required
- Bachelor's degree in Engineering
- 3 or more years of relevant experience
- Knowledge of process validation
- Knowledge of equipment IQ
- Knowledge of computer software validation
- Technical writing skills
- Strong communication skills in English and Spanish
- Investigation and root cause analysis skills
- Knowledge of statistical techniques
- Ability to meet schedules, project objectives, and deadlines
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
