The Role
Provides engineering support for pharmaceutical and biotech manufacturing operations, including troubleshooting, process optimization, equipment upgrades, system modifications, validation, qualification, deviations, and capital projects. Ensures GMP and regulatory compliance while collaborating with Manufacturing, Maintenance, Quality, Validation, Facilities, Utilities, and Process Development teams. Monitors performance, recommends improvements, mentors personnel, and supports 24/7 operations, including nights, weekends, extended hours, and non-standard shifts.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- Provide technical engineering support to daily manufacturing operations, including troubleshooting, process optimization, equipment upgrades, replacements, and modifications.
- Ensure manufacturing activities are performed in compliance with corporate policies, industry standards, GMP requirements, and applicable regulatory requirements.
- Provide solutions to technical problems of moderate scope and complexity under general supervision.
- Evaluate, select, and apply standard engineering techniques, basic principles, and procedures to resolve operational issues.
- Serve as a technical resource for processes, equipment, and systems during troubleshooting activities and cross-functional discussions.
- Become actively involved in daily manufacturing operations when needed to meet production schedules or resolve complex technical issues.
- Monitor manufacturing processes and performance indicators and provide recommendations for problem resolution and process improvement.
- Provide troubleshooting guidance and mentorship to manufacturing personnel and other team members.
- Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation to develop requirements and recommendations for process and system modifications.
- Support manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and New Product Introductions (NPI).
- Apply process, operational, scientific, compliance, analytical, and troubleshooting expertise to support manufacturing operations.
- Organize, analyze, and present results and recommendations related to operational issues and engineering projects.
- Apply engineering principles to the design and implementation of system modifications, experiments, and capital projects.
Qualifications:
- Bachelor’s degree in Mechanical, Electrical, Chemical Engineering, or a related engineering discipline.
- Experience with equipment and/or process troubleshooting in a regulated manufacturing environment.
- Knowledge of pharmaceutical and/or biotechnology processes and GMP production operations.
- Understanding of engineering principles, manufacturing processes, and equipment/system operations.
- Strong organizational and technical writing skills.
- Proficient presentation and communication skills in English and Spanish.
- Strong analytical and problem-solving skills.
- Ability to evaluate technical problems, identify potential solutions, and apply standard engineering techniques and principles.
- Ability to work effectively with cross-functional teams, including Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation.
- Ability to support manufacturing operations during non-standard shifts, including nights, weekends, and extended hours, based on business needs.
- Proficient presentation & communication skills in English and Spanish
- Non Standard Shift: (2/3/2) days shift Example: Week 1: (Mon-Tues (12hrs shift)) / Fri-Sat-Sun (12 hrs shift) Week 2: Wed-Thurs( 12 hrs shift)
- Support 24/7 manufacturing operations, including extended hours, nights, and weekends as required by business needs.
Skills Required
- Bachelor’s degree in Mechanical, Electrical, Chemical Engineering, or a related engineering discipline
- Experience troubleshooting equipment and/or processes in a regulated manufacturing environment
- Knowledge of pharmaceutical and/or biotechnology processes and GMP production operations
- Understanding of engineering principles, manufacturing processes, and equipment or system operations
- Strong organizational and technical writing skills
- Proficient presentation and communication skills in English and Spanish
- Strong analytical and problem-solving skills
- Ability to evaluate technical problems, identify solutions, and apply standard engineering techniques
- Ability to work effectively with cross-functional manufacturing, maintenance, quality, validation, facilities, utilities, and process development teams
- Ability to support non-standard shifts, including nights, weekends, extended hours, and 24/7 manufacturing operations
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The Company
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
