Engineer PRQN- 786

ProQualityNetwork; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Loxo seeks an Engineer to provide technical support for continuous daily manufacturing operations in a regulated setting. You will troubleshoot equipment and processes, drive improvements, and collaborate with cross-functional teams to ensure compliance with GMP standards.

The role emphasizes process optimization, equipment upgrades, and participation in deviations, validations, and new product introductions, with non-standard shifts as needed.

Qualifications

• Bachelor’s degree in Engineering and at least 2 years of engineering experience.
• Educational background in Mechanical, Electrical, Chemical, or related Engineering disciplines.
• Experience or exposure to pharmaceutical/biotech GMP environments preferred.

Responsibilities

• Provide engineering solutions to moderate complexity technical problems.
• Support equipment and process troubleshooting during daily manufacturing operations.
• Develop and drive process optimization strategies and equipment upgrades.
• Collaborate with Manufacturing, Maintenance, Process Development, QA, and Validation teams.

Skills

Analytical problem-solving

Technical writing

Bilingual English/Spanish

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Mechanical / Electrical / Chemical engineering background

Tools

Validation protocols

Equipment qualification

GMP documentation systems

Job description

Work Schedule: Non-Standard Shifts; availability to work different shifts, nights, extended hours, and weekends based on business needs

Contract Duration: 5 months

Positions Available: 1

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.

Position Summary

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

The selected candidate will work under general supervision to apply engineering principles and standard techniques to resolve operational issues, support manufacturing activities, and implement process or equipment improvements. The role will also collaborate closely with cross-functional teams to ensure operations remain compliant with applicable company policies, industry standards, and regulatory requirements.

This position supports non-standard shift manufacturing operations, including nights, extended hours, and weekends as required by business needs.

Key Responsibilities

• Provide engineering solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, principles, and procedures to resolve operational issues.
• Support equipment and process troubleshooting during daily manufacturing operations.
• Function as a technical resource for processes, equipment, and systems during troubleshooting activities and cross-functional discussions.
• Become actively involved in manufacturing operations when needed to maintain schedules or resolve complex technical issues.
• Monitor manufacturing processes and equipment performance, identify issues, recommend solutions, and provide troubleshooting support.
• Develop and support process optimization strategies, equipment upgrades, replacements, and system or process modifications.
• Work collaboratively with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for process and system modifications.
• Support the execution of manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and New Product Introduction (NPI) activities.
• Apply engineering, scientific, operational, analytical, and troubleshooting knowledge to support manufacturing operations.
• Organize, analyze, and present results related to operational issues and engineering projects.
• Apply basic engineering principles to the design and implementation of system modifications, experiments, and capital projects.
• Support routine technical assignments involving investigation and evaluation of a defined number of variables.
• Assist with engineering projects, including design activities, technical evaluations, equipment modifications, and project documentation.
• Work with consultants, architects, and engineering firms when required to support engineering and design activities.
• Review and provide technical input on quotes for equipment modifications or installations.
• Assist with developing basic project cost estimates and schedules.
• Ensure engineering and manufacturing activities are performed in compliance with GMPs, applicable regulatory requirements, and established company procedures.
• Support 24/7 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as business needs require.

Education & Experience

• Bachelor’s degree in Engineering with at least 2 years of engineering experience.
• Educational background in Mechanical, Electrical, Chemical, or related Engineering disciplines.

Preferred Qualifications

• Working knowledge of pharmaceutical or biotechnology processes and GMP manufacturing operations.
• Experience with equipment and/or process troubleshooting in a regulated environment.
• Familiarity with validation processes and validation protocol execution requirements.
• Experience working with documentation in a highly regulated environment.
• Ability to interpret and apply GMP and GLP requirements.
• Ability to apply engineering principles and scientific knowledge to manufacturing operations.
• Experience supporting equipment qualification and/or process validation activities.
• Strong analytical problem-solving and applied engineering skills.
• Ability to develop solutions to routine technical problems within a defined scope.
• Technical writing and report preparation skills.
• Experience with validation protocol writing is preferred.
• Strong verbal, written, and presentation skills in English and Spanish.
• Strong organizational and time-management skills.
• Ability to adapt to changing priorities and manage change effectively.
• Computer literacy and ability to work with specialized equipment and computer systems as appropriate.
• Ability to communicate technical information effectively in cross-functional environments.

This position is based in a manufacturing environment and requires onsite support of non-standard shift operations. The selected candidate must be available to work different shifts, nights, extended hours, and weekends when required to support business and manufacturing needs.