Senior Risk Control Consultant Jobs in Bayamon, PR

The Sr. Engineer independently leads and directs process optimization, troubleshooting, and engineering activities across operations, manufacturing, pilot plant, and capital project environments. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and capital projects. The Sr. Engineer develops, organizes, analyzes, and presents complex technical results and serves as a recognized technical expert in assigned engineering areas.

• Complete complex or novel assignments requiring development of new or improved engineering techniques and procedures.
• Develop engineering policies and procedures that impact multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and technicians on both ongoing and project-based activities.
• Apply advanced engineering techniques and adapt methodologies to solve complex technical challenges.
• Utilize engineering knowledge across multiple disciplines to support a broad variety of assignments.
• Serve as a peer‑recognized technical specialist with responsibility for determining methodologies in assigned areas.
• Apply mature engineering judgment in planning and conducting projects.
• Perform additional duties as assigned.
• Develop technical solutions to complex problems requiring creativity, innovation, and advanced engineering judgment.
• Collaborate with manufacturing, research, process development, utilities, facilities, quality assurance, and validation teams to define requirements and recommendations for highly complex system or facility modifications.
• Work with project managers to complete engineering and construction projects within schedule, budget, and quality constraints.
• Coordinate work with consultants, architects, and engineering firms to develop standard design documents.
• Develop departmental or project budgets involving multiple engineering disciplines.
• Perform technical assessments of equipment in regulated pharmaceutical or biotechnology environments.
• Prepare, review, and approve technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Evaluate equipment failures, performance issues, maintenance history, operating conditions, and impact on product, process, quality, and equipment qualification status.
• Assess equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and fitness for intended use.
• Review engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
• Develop clear, factual, and scientifically justified conclusions and recommendations.
• Provide technical support for deviations, investigations, CAPAs, change controls, risk assessments, and compliance commitments.
• Ensure technical assessments are complete, traceable, inspection‑ready, and supported by objective evidence.
• Apply knowledge of cGMP, GLPs, and regulated documentation practices.
• Collaborate with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain and evaluate technical information.
• Manage contractors and vendors effectively.
• Demonstrate strong field presence and willingness to inspect equipment and verify operating conditions.
• Lead and mentor engineering staff; delegate and manage project work.
• Handle multiple projects simultaneously and determine when internal or external resources are required.
• Demonstrate expertise in at least three engineering technology areas.
• Apply scientific and engineering theory, calculations, and creative problem‑solving to develop hypotheses and technical approaches.
• Utilize financial analysis tools for project cost development.
• Demonstrate skills in negotiation, facilitation, conflict resolution, and team building.

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes and regulated documentation.
• Ability to operate specialized laboratory equipment and engineering software.
• Ability to interpret and apply GLPs and GMPs.
• Strong applied engineering and problem‑solving skills.
• Technical report writing and verbal communication skills.
• Understanding of validation protocol execution requirements.
• Skills in technical presentations, personal organization, validation protocol writing, change management, and equipment‑specific technical expertise.
• Analytical problem‑solving and computer literacy.
• Ability to manage multiple projects and determine resource needs.
• Collaboration, facilitation, scheduling, and project completion skills.

• Doctorate OR
• Master’s degree + 2 years of engineering experience OR
• Bachelor’s degree in Engineering + 4 years of engineering experience.

• Experience performing technical assessments in regulated pharmaceutical or biotechnology environments.
• Experience with purification, fermentation, utilities, or pharmaceutical manufacturing systems.
• Strong technical writing, communication, and problem‑solving skills.
• Ability to independently manage multiple assessments and deliverables.
• Experience supporting deviations, CAPAs, change controls, and risk assessments.
• Strong field presence and hands‑on equipment evaluation experience.

• Administrative shift
• 1-year contract with possible extension