Senior Engineer ProQN958

ProQualityNetwork; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

ProQualityNetwork in Juncos, PR seeks a Senior Engineer to independently lead process characterization, optimization strategies, and troubleshoot operational issues across manufacturing, pilot plant, and capital projects.

The selected candidate will apply advanced engineering principles to design and implement system modifications, run experiments, and develop technical assessments with recommendations to improve safety, quality, and efficiency. This role is on-site and contract for 6 months.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering with hands-on biopharma experience
• Experience in regulated pharmaceutical/biotechnology environments
• Ability to independently conduct technical assessments and lead equipment improvements
• Experience supporting manufacturing equipment and systems in regulated settings

Responsibilities

• Perform system owner assessments and engineering impact assessments related to equipment failures, deviations, and quality events
• Support technical investigations, identify failure mechanisms, and develop CAPAs to minimize recurrences
• Evaluate applicability of CAPAs and lessons learned across equipment, systems, and manufacturing areas
• Manage engineering activities in IBM Maximo including work order reviews, pre/post-approval actions, maintenance coordination, and closure
• Develop and revise PM strategies, job plans, inspection requirements, and SOPs
• Implement engineering controls and complete corrective actions for safety incidents and INCA records

Skills

System Owner assessments

CAPA management

Troubleshooting

Cross-functional collaboration

PM strategies

Documentation & GMP knowledge

Process instrumentation

Education

Doctorate in Engineering

Master’s degree in Engineering (2+ years)

Bachelor’s degree in Engineering (4+ years)

Tools

IBM Maximo

Job description

Location: Juncos, PR (Open to Puerto Rico residents only)

Work Arrangement: On-site, Administrative Shift

Number of Positions: 3

Contract Duration: 6 months

SUMMARY

Our client is seeking a Senior Engineer to independently lead and support process characterization, optimization strategies, and troubleshooting of operational issues within manufacturing, operations, pilot plant, and capital project environments.

The selected candidate will apply advanced engineering principles to the design and implementation of system modifications, process improvements, experiments, and capital projects. Responsibilities include developing, analyzing, and presenting technical assessments and recommendations to address complex operational challenges and engineering initiatives.

Preferred Qualifications and Experience

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering, with hands-on experience in biopharmaceutical manufacturing.
• Experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment.
• Ability to independently conduct technical assessments, manage corrective actions, and lead equipment improvement initiatives.

The ideal candidate will have experience in the following areas:

• Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
• Supporting technical investigations, identifying equipment failure mechanisms, and developing Corrective and Preventive Actions (CAPAs) to minimize recurrence.
• Evaluating the applicability of CAPAs and lessons learned across other equipment, systems, and manufacturing areas.
• Managing engineering activities in IBM Maximo, including technical work order reviews, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
• Developing and revising Preventive Maintenance (PM) strategies, Job Plans, inspection requirements, and Standard Operating Procedures (SOPs).
• Implementing engineering controls and completing corrective actions associated with safety incidents and INCA records.
• Supporting equipment troubleshooting, repair coordination, obsolete equipment replacement, spare parts evaluations, and equipment modernization initiatives.
• Working with biopharmaceutical manufacturing equipment, including centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation.
• Preparing technical reports and assessment rationales, maintaining accurate and traceable supporting documentation, and completing assigned actions within established deadlines.
• Collaborating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
• Managing multiple assignments simultaneously and prioritizing activities based on safety, quality, and operational requirements.

FUNCTIONS

General

• Complete complex or novel assignments that require developing new or improved engineering techniques and procedures.
• Develop engineering policies and procedures that may impact multiple organizational units.
• Supervise, coordinate, and review the work of a small team of engineers, associates, and/or technicians on an ongoing or project-specific basis.
• Apply advanced engineering techniques and modify existing methods within the area of engineering expertise.
• Apply engineering principles and practices beyond the primary area of discipline to a broad range of assignments in related fields.
• Serve as a recognized engineering technology specialist in at least one area, with responsibility for determining the appropriate methodologies within that specialty.
• Apply advanced engineering knowledge to project planning and execution.

Additional functions may be assigned as needed.

• Develop technical solutions to complex engineering problems requiring ingenuity, creativity, and independent judgment.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to establish requirements and recommendations for major or highly complex system and facility modifications.
• Partner with project managers to deliver design and engineering projects within established schedules, budgets, and quality requirements.
• Coordinate consultants, architects, and engineering firms in the development of standardized design documentation.
• Develop departmental or project budgets covering multiple engineering disciplines, either for assigned project areas or smaller projects in their entirety.

EDUCATION

Candidates must meet one of the following educational and experience requirements:

• Doctorate in Engineering; OR
• Master’s degree in Engineering with at least 2 years of engineering experience; OR
• Bachelor’s degree in Engineering with at least 4 years of engineering experience.

COMPETENCIES / SKILLS

Candidates should demonstrate the following technical knowledge and capabilities:

Technical Knowledge and Engineering Skills

• Working knowledge of pharmaceutical and biotechnology manufacturing processes.
• Familiarity with equipment and process validation requirements.
  • Experience with technical documentation in highly regulated environments.
  • Ability to operate specialized laboratory equipment and computer systems, as applicable.
  • Knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) and their practical application.
  • Ability to apply engineering principles and scientific knowledge to manufacturing operations.
  • Ability to identify and resolve routine technical problems within the assigned scope.
  • Comprehensive understanding of validation protocol execution requirements.
  • Specialized equipment and process expertise.
  • In-depth knowledge of validation processes and requirements for new equipment installations.
  • Established expertise in at least three distinct areas of engineering technology.
  • Working knowledge of financial analysis tools.

Analytical, Technical, and Communication Skills

• Strong problem-solving and applied engineering skills.
• Analytical thinking and the ability to develop solutions to technical challenges of varying complexity.
• Ability to apply scientific and engineering theories, calculations, and creative approaches to develop technical hypotheses and solutions.
• Technical report writing and presentation skills.
• Effective verbal communication and interpersonal skills.
• Computer literacy and technical proficiency.
• Ability to adapt to different communication and working styles.
• Ability to independently identify when additional internal or external resources are needed to resolve technical issues.

Project Management and Organizational Skills

• Strong personal organization and time management.
• Ability to manage multiple projects and priorities simultaneously.
• Schedule development, coordination, and follow-up.
• Basic to advanced project management capabilities.
• Ability to coordinate, delegate, and manage the work of others.
• Project cost development and budget management.
• Ability to ensure timely completion and follow-up of assigned activities.
• Experience managing contractors, consultants, and vendors.

Leadership and Collaboration

• Effective collaboration and facilitation skills.
• Leadership and team-building capabilities.
• Negotiation and persuasion skills.
• Conflict resolution and change management.
• Ability to coordinate cross-functional teams and manage competing priorities.
• Ability to provide technical guidance and support to engineering teams and project stakeholders.