The Role
Provide engineering support for 24/7 biotechnology manufacturing operations, including equipment troubleshooting, process optimization, modifications, validation, qualification, deviations, and new product introduction. Collaborate with manufacturing, maintenance, quality, facilities, utilities, and validation teams. Analyze operational data, support capital and construction projects, resolve technical issues, and ensure compliance with GMP/GLP and regulatory requirements, with a focus on purification operations, chromatography, and UF/DF processes.
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).
- Experience in biotechnology processes, specifically in purification operations.
- Knowledge of chromatography and Ultrafiltration/Diafiltration (UF/DF) techniques.
- Understanding of purification equipment, processes, and operational best practices within a biotechnology manufacturing environment.
- Ability to follow GMP/cGMP procedures and documentation requirements in purification operations.
- Strong troubleshooting and problem-solving skills related to purification processes.
- Administrative Shift
Skills Required
- Bachelor's degree in Engineering, such as Mechanical, Electrical, Chemical, Industrial, or a related field
- Experience in biotechnology processes, specifically purification operations
- Knowledge of chromatography and Ultrafiltration/Diafiltration techniques
- Understanding of purification equipment, processes, and operational best practices in a biotechnology manufacturing environment
- Ability to follow GMP/cGMP procedures and documentation requirements in purification operations
- Strong troubleshooting and problem-solving skills related to purification processes
- Availability for an administrative shift and 24/7 manufacturing support, including nights and weekends as needed
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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
