Responsibilities:
- Develop, optimize, and implement manufacturing processes, procedures, and production layouts.
- Provide engineering support to manufacturing operations, equipment, and production processes.
- Evaluate manufacturing processes and equipment to identify opportunities for improvement, efficiency, quality, and productivity.
- Support equipment installation, qualification, process validation, and implementation activities.
- Develop and maintain process documentation, procedures, and technical reports.
- Participate in investigations, troubleshooting, root cause analysis, and corrective/preventive actions.
- Apply statistical techniques and data analysis to monitor and improve manufacturing processes.
- Collaborate with cross-functional teams to support manufacturing projects and meet established objectives and timelines.
- Identify and implement continuous improvement opportunities within the manufacturing environment.
- Ensure processes and documentation comply with applicable quality and regulatory requirements.
Qualifications:
- Bachelor’s degree in Engineering or a related technical field.
- 4+ years of relevant engineering or manufacturing experience preferred.
- Experience in manufacturing, process engineering, validation, equipment qualification, or related areas.
- Knowledge of Process Validation, Equipment IQ/OQ/PQ, and/or Computer System Validation (CSV) preferred.
- Experience with investigation and root cause analysis.
- Knowledge of statistical methods and process improvement techniques.
- Strong technical writing, documentation, and communication skills.
- Ability to work effectively with cross-functional teams.
- Strong organizational and time-management skills with the ability to manage multiple projects and deadlines.
- Bilingual English/Spanish communication skills preferred.
Skills Required
- Bachelor’s degree in Engineering or a related technical field.
- 4+ years of relevant engineering or manufacturing experience.
- Experience in manufacturing, process engineering, validation, equipment qualification, or related areas.
- Knowledge of Process Validation, Equipment IQ/OQ/PQ, and/or Computer System Validation (CSV).
- Experience with investigations and root cause analysis.
- Knowledge of statistical methods and process improvement techniques.
- Strong technical writing, documentation, and communication skills.
- Ability to work effectively with cross-functional teams.
- Strong organizational and time-management skills, including the ability to manage multiple projects and deadlines.
- Bilingual English/Spanish communication skills.
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
