Engineer - IPSD Engineering

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

BioPharma Consulting JAD Group provides engineering support across operations, manufacturing, pilot plant, and capital projects. The role focuses on process optimization, troubleshooting, and applying engineering principles to system modifications and experiments.

Strong analytical skills are required to organize, interpret, and present results for operational or engineering activities. Availability for a 6-month contract with flexible shifts and extended hours may be needed.

Qualifications

• Masterfs degree in Engineering or Bachelorfs with 2 years of engineering experience.
• Working knowledge of pharmaceutical, biotech, or medical device 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.
• Strong problem-solving and applied engineering skills.
• Technical report writing proficiency.
• Experience identifying and managing CAPAs.
• Proficiency in statistical analysis and Design of Experiments (DOE).
• Experience with packaging equipment, process characterization, validation, monitoring, and optimization.
• Solid understanding of validation protocol execution.
• Skills: technical presentations, organization, validation protocol writing, change management, equipment knowledge, analytical problem solving, computer literacy.

Responsibilities

• 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.
• Perform additional engineering duties as assigned.

Skills

Process optimization

Troubleshooting

Analytical skills

Design of Experiments

Validation processes

Regulatory compliance (GLPs/GMPs)

Technical report writing

CAPA management

Cross-functional collaboration

Project coordination

Education

Masterfs degree in Engineering

Bachelorfs degree in Engineering + 2 years of engineering experience

Job description

Under general supervision, this role provides engineering support across operations, manufacturing, pilot plant, and capital project environments. Responsibilities include process optimization, troubleshooting operational issues, and applying engineering principles to system modifications, experiments, and small‑scope projects. The role requires strong analytical skills to organize, interpret, and present results for operational or engineering activities.

Responsibilities:

• 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.
• Perform additional engineering duties as assigned.

• Master’s degree in Engineering OR

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

Preferred Qualifications

• Working knowledge of pharmaceutical, biotech, or medical device 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.
• Strong problem‑solving and applied engineering skills.
• Technical report writing proficiency.
• Experience identifying and managing CAPAs.
• Proficiency in statistical analysis and Design of Experiments (DOE).
• Experience with packaging equipment, process characterization, validation, monitoring, and optimization.
• 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 & Contract Details

• 1st Shift
• 2nd Shift
• 6‑month contract with possible extension
• Availability to support non‑standard shifts, extended hours, nights, weekends, and holidays.