Engineer- PRQN 685

Frey Consulting Group; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Frey Consulting Group is seeking an Engineer to support daily manufacturing operations with a focus on troubleshooting, process optimization, and equipment upgrades.

Under supervision, you will analyze issues, apply engineering principles, and work with cross-functional teams to ensure safe, compliant operations in a regulated environment. Night/weekend shifts may be required.

Qualifications

• Master's in Engineering or Bachelor's with 2+ years of experience.
• Experience in regulated manufacturing environments preferred.
• Knowledge of GMP/GLP practices and documentation.
• Ability to work with cross-functional teams and adapt to change.

Responsibilities

• Provide technical engineering support for daily manufacturing operations.
• Assist with process optimization, equipment upgrades, and capital projects.
• Analyze issues, interpret results, and offer technical solutions.
• Collaborate with Manufacturing, Maintenance, QA, and Validation teams.
• Support deviations, validations, NPI, and documentation per GMP.

Skills

Strong problem-solving

Analytical troubleshooting

Effective communication

Cross-functional collaboration

Education

Master's degree in Engineering

Bachelor's degree in Engineering with 2+ years experience

Job description

Work Schedule: On-site- Second or Third Shift a Nonstandard Shift

Shift Requirements: Must be available to work different shifts and/or weekends based on business needs

Position Available: 1

Contract Duration: 1 year

This opportunity is available only to direct individual candidates. Third-party contractors, staffing agencies, vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Position Summary

Our client is seeking an Engineer to provide technical engineering support for daily manufacturing operations. This role will focus on troubleshooting, process optimization, equipment and process upgrades, replacements, and modifications within a regulated manufacturing environment.

Under general supervision, the Engineer will apply fundamental engineering principles to support system modifications, experiments, process improvements, and capital projects. The position will also analyze operational issues, interpret results, and provide technical solutions to problems of moderate scope and complexity.

The Engineer will work closely with cross-functional teams to ensure manufacturing operations are executed safely, efficiently, and in compliance with applicable corporate policies, industry standards, and regulatory requirements.

This role supports non-standard manufacturing operations and may require nights, extended hours, and weekends based on business needs.

Key Responsibilities

Operations & Engineering Support

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, basic principles, and procedures under general supervision.
• Perform engineering assignments with clearly defined objectives that require investigation of a limited number of variables.
• Initiate and complete routine technical engineering tasks.
• Provide technical engineering support to continuous daily manufacturing operations.
• Support troubleshooting activities, process optimization strategies, equipment upgrades, replacements, and process or equipment modifications.
• Apply process, operational, scientific, and engineering knowledge to support manufacturing operations.
• Organize, analyze, and present results and recommendations related to operational issues and engineering projects.

Troubleshooting & Manufacturing Support

• 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 necessary to meet production schedules or resolve complex technical problems.
• Monitor manufacturing processes and operational performance indicators.
• Identify potential issues, recommend solutions, and provide troubleshooting guidance and mentorship.
• Apply analytical and problem-solving skills to identify opportunities for process and operational improvements.
• Support manufacturing operations during non-standard shifts, including extended hours and weekends, as required.

Cross-Functional Collaboration

• Work closely with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
• Develop requirements and recommendations for process, equipment, and system modifications.
• Participate in multifunctional discussions related to manufacturing operations, troubleshooting, and engineering improvements.
• Collaborate with relevant stakeholders to ensure engineering solutions support operational, quality, and compliance requirements.

Quality & Validation Support

• Support the execution of manufacturing and quality systems, including:
• Deviations
• Process validation
• Procedures
• Training
• New Product Introductions (NPI)
• Support validation and qualification activities in accordance with established requirements.
• Apply basic compliance knowledge and follow applicable GMP requirements.
• Ensure engineering and manufacturing activities are performed in accordance with current corporate policies, industry standards, and applicable regulatory requirements.
• Routinely evaluate equipment and process performance for operational and regulatory compliance.

Design & Capital Projects

• Apply basic engineering principles to the design and implementation of:
• System modifications
• Process improvements
• Capital projects
• Work under the direction of project managers to support engineering, design, and construction projects.
• Assist with developing requirements, recommendations, schedules, and technical documentation for engineering projects.
• Support projects within established timelines and project objectives.
• Work with consultants, architects, and engineering firms as needed for engineering and design activities.
• Obtain and evaluate quotes related to equipment modifications or installations.
• Develop basic project cost estimates and schedules.

Education & Experience

Required:

• Master's degree in Engineering OR
• Bachelor's degree in Engineering with at least 2 years of engineering experience.

Preferred Qualifications

• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Familiarity with validation processes and equipment qualification.
• Experience working with documentation in a highly regulated environment.
• Ability to interpret and apply Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Ability to apply engineering principles and science to manufacturing and production operations.
• Understanding of validation protocol execution requirements.
• Experience supporting deviations, equipment qualification, process validation, and New Product Introduction activities.
• Ability to operate specialized laboratory equipment and computer systems, as applicable.
• Strong problem-solving and applied engineering skills.
• Analytical troubleshooting capabilities.
• Basic technical report-writing skills.
• Basic technical presentation skills.
• Familiarity with validation protocol writing.
• Strong verbal and written communication skills.
• Strong organizational and time-management skills.
• Ability to effectively manage and adapt to change.
• Technical knowledge related to assigned equipment and systems.
• Computer literacy and ability to work with applicable engineering and business systems.