Engineer-Reliability & Process at BioPharma… · Juncos

In this role, you will support continuous daily operations by executing troubleshooting activities, process optimization strategies, equipment upgrades, replacements, and system modifications. You will ensure all activities comply with corporate policies, industry standards, and applicable regulatory requirements. This position supports non‑standard shift operations, including nights and weekends.

Functions

• Provide solutions to technical problems of moderate scope and complexity.

• Evaluate, select, and apply standard engineering techniques and procedures; seek guidance for unusual or complex issues.

• Perform assignments with clear objectives requiring investigation of a limited number of variables.

• Initiate and complete routine technical tasks independently.

• Serve as a technical expert for equipment and systems during troubleshooting activities.

• Engage directly in daily operations when needed to meet production schedules or resolve complex issues.

• Conduct routine audits of equipment performance and regulatory compliance for systems of significant complexity.

• Collaborate with cross‑functional teams (Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, Validation) to define requirements and recommendations for system or process modifications.

• Support project managers in completing design, engineering, and construction projects within established timelines and budgets.

• Partner with consultants, architects, and engineering firms to develop standard design documentation.

• Obtain and evaluate quotes for equipment modifications or installations.

• Prepare basic project cost estimates and schedules.

• Provide engineering solutions to technical problems of moderate complexity.

• Apply standard engineering principles, techniques, and procedures under general supervision.

• Act as a technical expert during troubleshooting and cross‑functional discussions.

• Participate in daily operations when needed to meet production goals or resolve complex issues.

• Monitor manufacturing processes for performance indicators; recommend corrective actions and provide troubleshooting guidance.

• Support manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and new product introductions.

• Apply scientific, operational, and compliance knowledge to support manufacturing operations.

• Analyze and present results for operational issues or engineering projects.

• Implement system modifications, experiments, and capital project activities.

• Support 24/7 operations, including extended hours and weekend coverage as required.

• Master’s degree in Engineering OR

• Bachelor’s degree in Engineering + 2 years of engineering experience

Preferred Qualifications

• Working knowledge of pharmaceutical or biotech processes.
• Familiarity with validation processes and documentation in regulated environments.
• Ability to operate specialized laboratory equipment and relevant software.
• Understanding and application of GLPs and GMPs.
• Ability to apply engineering science to production environments.
• Strong problem‑solving and applied engineering skills.
• Basic technical report writing and presentation skills.
• Effective verbal communication skills.
• Solid understanding of validation protocol execution.
• Skills in:
  • Technical presentations
  • Personal organization
  • Validation protocol writing
  • Change management
  • Equipment‑specific technical knowledge
  • Analytical problem solving
  • Computer literacy

Shift Information

• 2nd Shift
• 3rd Shift
• 1‑year contract with possible extension