Summary:
We are seeking a Manufacturing Engineer to join our team and support a client within the medical device industry. This role will provide engineering support for manufacturing operations, including process development and improvement, equipment and process validation, troubleshooting, technical documentation, and production line support. The Manufacturing Engineer will collaborate with Quality, Operations, Validation, and other cross-functional teams to improve manufacturing performance, maintain compliant processes, and resolve technical issues. The ideal candidate will have hands-on experience in a regulated manufacturing environment with a strong understanding of equipment qualification and process validation.
Scope of Work / Key Responsibilities:
- Provide day-to-day engineering support to manufacturing and production operations.
- Develop, improve, and maintain manufacturing processes, procedures, methods, and production workflows.
- Identify and implement opportunities to improve process efficiency, product quality, yield, reliability, and manufacturing performance.
- Troubleshoot manufacturing process and equipment issues and implement appropriate corrective actions.
- Support the installation, modification, and qualification of manufacturing equipment, tooling, and fixtures.
- Develop, execute, and document equipment qualification activities, including IQ, OQ, and PQ, as applicable.
- Support process validation activities, including process characterization, OQ, PQ, data analysis, and validation reporting.
- Develop and execute engineering studies, protocols, test plans, and technical reports.
- Monitor and analyze manufacturing data to identify trends, process variation, and opportunities for improvement.
- Apply statistical techniques such as SPC, process capability analysis, and Design of Experiments (DOE) where appropriate.
- Support root cause investigations related to manufacturing processes, equipment, and product quality.
- Develop and revise SOPs, manufacturing procedures, work instructions, and other controlled documentation.
- Provide engineering support during production runs, special builds, process changes, equipment modifications, and validation activities.
- Support change controls, deviations, CAPAs, and other quality system activities related to manufacturing processes and equipment.
- Collaborate with Quality, Manufacturing, Operations, Automation, and other technical teams to resolve issues and implement improvements.
- Support Computer System Validation (CSV) and Manufacturing Execution System (MES) activities associated with manufacturing processes and equipment, as applicable.
- Ensure manufacturing processes, equipment, procedures, and documentation comply with applicable GMP, Quality System, and medical device regulatory requirements.
- Support the introduction or transfer of new products, components, equipment, and processes into manufacturing when required.
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Required Qualifications:
- Bachelor’s degree in Engineering or a related technical discipline.
- Minimum of 2 years of relevant Manufacturing Engineering, Process Engineering, or related experience.
- Experience supporting manufacturing processes and production operations.
- Experience with equipment qualification and/or process validation.
- Understanding of IQ, OQ, PQ, and the process validation lifecycle.
- Strong troubleshooting, analytical, and problem-solving skills.
- Experience developing and maintaining engineering and manufacturing documentation.
- Ability to analyze technical and manufacturing data and develop appropriate recommendations.
- Strong communication and teamwork skills with the ability to work effectively across multiple functional areas.
- Experience working within a regulated manufacturing environment.
Preferred Qualifications:
- Previous experience within the medical device industry.
- Hands-on experience developing and executing IQ, OQ, PQ, and process validation protocols.
- Experience with DOE, Minitab, SPC, and process capability analysis.
- Experience with equipment installation, qualification, and manufacturing line support.
- Experience developing SOPs, work instructions, and manufacturing procedures.
- Experience supporting CAPAs, deviations, investigations, and change controls.
- Familiarity with Computer System Validation (CSV).
- Experience with MES or other computerized manufacturing systems.
- Knowledge of Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
Top Candidate Priorities:
1. Manufacturing & Validation Experience
Hands-on experience supporting manufacturing operations, including equipment qualification and process validation activities.
2. Problem Solving & Process Improvement
Demonstrated ability to troubleshoot manufacturing issues, perform root cause analysis, and implement improvements to processes, equipment, quality, and productivity.
3. Cross-Functional Collaboration
Ability to work effectively with Manufacturing, Quality, Operations, Validation, and Engineering teams in a regulated manufacturing environment.
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Job Details:
Contract Duration: 1+ years
Location: On Site (South East, Puerto Rico)
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Why Apply?
This is a unique opportunity to work on a high-impact project in the pharmaceutical sector with a respected and growing firm. At SoltechPR, we value our people and are committed to offering meaningful work, professional development, and a supportive team environment. If you’re ready to bring your expertise to a major construction initiative in the regulated industry, we’d love to hear from you.
Apply today and become part of something impactful!