The Role
Provides engineering support for 24/7 pharmaceutical and biotechnology manufacturing operations. Responsibilities include troubleshooting equipment and processes, optimizing performance, supporting modifications, validation, qualification, deviations, new product introduction, and capital projects. Collaborates with manufacturing, maintenance, quality, facilities, and validation teams while ensuring GMP/GLP and regulatory compliance. Requires flexibility for 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, upgrades, replacements, and equipment modifications.
- Serve as a technical resource for equipment, processes, and systems during troubleshooting and cross-functional discussions.
- Monitor manufacturing processes and equipment performance, identify operational issues, and recommend solutions.
- Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams on process and system improvements.
- Support deviations, equipment qualification, process validation, procedures, training, and New Product Introduction activities.
- Analyze operational data and present findings and recommendations for engineering projects and manufacturing issues.
- Apply engineering principles to system modifications, experiments, equipment improvements, and capital projects.
- Support design and construction projects, including reviewing technical documents, equipment quotes, project schedules, and cost estimates.
- Evaluate and resolve technical problems using analytical and troubleshooting skills while working under general supervision.
- Ensure manufacturing activities comply with corporate policies, industry standards, GMP/GLP requirements, and applicable regulatory expectations.
- Provide engineering support for 24/7 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.
Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field).
- Able to support non-standard shift manufacturing operations that may nights and weekends.
- Experience or working knowledge of pharmaceutical or biotechnology manufacturing processes.
- Familiarity with GMP/GLP and highly regulated manufacturing environments.
- Knowledge of equipment qualification and process validation.
- Experience with validation protocol execution or protocol writing.
- Ability to apply engineering principles and scientific knowledge to manufacturing operations.
- Strong troubleshooting, analytical problem-solving, and technical decision-making skills.
- Ability to prepare technical reports and presentations.
- Strong verbal and written communication skills.
- Experience supporting equipment, process, or system modifications.
- Computer proficiency and ability to work with specialized laboratory or manufacturing equipment.
- Ability to manage changing priorities and work effectively with cross-functional teams.
- Strong organizational skills and attention to detail.
- Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
Skills Required
- Bachelor's degree in Engineering, such as Mechanical, Electrical, Chemical, Industrial, or a related field
- Ability to support non-standard manufacturing shifts, including nights, weekends, and extended hours
- Experience or working knowledge of pharmaceutical or biotechnology manufacturing processes
- Familiarity with GMP/GLP and highly regulated manufacturing environments
- Knowledge of equipment qualification and process validation
- Experience with validation protocol execution or protocol writing
- Ability to apply engineering principles and scientific knowledge to manufacturing operations
- Strong troubleshooting, analytical problem-solving, and technical decision-making skills
- Ability to prepare technical reports and presentations
- Strong verbal and written communication skills
- Experience supporting equipment, process, or system modifications
- Computer proficiency and ability to work with specialized laboratory or manufacturing equipment
- Ability to manage changing priorities and work effectively with cross-functional teams
- Strong organizational skills and attention to detail
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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
