Title: Senior Engineer-35611

Location: Juncos, Puerto Rico

Important Notice: This opportunity is available only for direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Work Schedule: Onsite | Administrative Shift (Must be available to work overtime, alternate shifts, weekends, and holidays based on business needs.)

Contract Duration: 1 year

Open Positions: 1

Position Summary

Our client is seeking a Senior Engineer to provide technical leadership in process optimization, equipment reliability, troubleshooting, and capital projects within a highly regulated pharmaceutical manufacturing environment.

In this role, you will independently lead engineering initiatives, apply advanced engineering principles to complex technical challenges, and support manufacturing operations through the design, implementation, and continuous improvement of equipment, systems, and processes. The successful candidate will collaborate across multiple functional areas while ensuring compliance with quality, safety, and regulatory requirements.

Key Responsibilities

Engineering & Technical Leadership

• Lead complex engineering assignments involving process optimization, troubleshooting, and continuous improvement initiatives.
• Develop and implement innovative engineering solutions for complex manufacturing and operational challenges.
• Apply advanced engineering principles to major system modifications, capital projects, and process improvements.
• Plan, organize, analyze, and interpret engineering data to support technical decisions and project objectives.
• Develop and improve engineering procedures, standards, and best practices across multiple organizational areas.
• Serve as a recognized Subject Matter Expert (SME) within a designated engineering discipline.
• Provide technical guidance, mentoring, and oversight to engineers, associates, and technicians.

Manufacturing & Equipment Reliability

• Own manufacturing equipment within the Computerized Maintenance Management System (CMMS), including:
• Work order approval and closure
• Preventive maintenance strategy development
• Spare parts management and optimization
• Equipment record accuracy and updates
• Collaborate with maintenance and engineering teams to develop and implement effective maintenance strategies.
• Improve equipment reliability by increasing availability, reducing downtime, and optimizing maintenance activities.
• Develop and monitor equipment performance metrics to identify opportunities for continuous improvement.
• Lead equipment enhancement and reliability improvement projects.
• Provide technical support for equipment troubleshooting and manufacturing operations.
• Perform change control assessments and ensure compliance with applicable engineering requirements.

Project & Design Engineering

• Design technical solutions for complex engineering challenges requiring creativity and sound engineering judgment.
• Partner with Manufacturing, Process Development, Research, Utilities, Facilities, Quality Assurance, and Validation teams to develop engineering requirements for system and facility modifications.
• Support capital and engineering projects, ensuring deliverables are completed on schedule, within budget, and in compliance with quality standards.
• Coordinate the work of consultants, contractors, architects, and external engineering firms.
• Assist in developing departmental and project budgets for engineering initiatives.

Compliance & Quality

• Ensure engineering activities comply with cGMP, GLP, and applicable regulatory requirements.
• Support equipment investigations, deviation management, and root cause analysis.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPAs) related to equipment and engineering systems.
• Participate in validation activities, including protocol development and execution.
• Promote Environmental, Health, and Safety (EHS) compliance throughout all engineering activities.

Minimum Qualifications

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

• Doctorate degree in Engineering or a related technical discipline.
• Master's degree in Engineering with a minimum of two (2) years of relevant engineering experience.
• Bachelor's degree in Engineering with a minimum of four (4) years of relevant engineering experience.

Required Qualifications

• Experience in pharmaceutical, biotechnology, or other highly regulated manufacturing environments.
• Working knowledge of pharmaceutical or biotech manufacturing processes.
• Experience with manufacturing equipment reliability and maintenance programs.
• Familiarity with validation processes and protocol execution.
• Experience working within Computerized Maintenance Management Systems (CMMS).
• Knowledge of change control, deviation investigations, and CAPA management.
• Understanding of engineering documentation within regulated environments.
• Ability to interpret and apply cGMP and GLP requirements.
• Experience supporting equipment troubleshooting and continuous improvement initiatives.
• Proficiency with Microsoft Office applications and standard engineering software.



Preferred Skills & Competencies

• Strong analytical thinking and engineering problem-solving abilities.
• Experience leading engineering and equipment improvement projects.
• Technical report writing and documentation skills.
• Effective verbal and written communication skills.
• Ability to manage multiple priorities and projects simultaneously.
• Strong collaboration and cross-functional teamwork skills.
• Project planning, scheduling, and execution experience.
• Leadership, coaching, and mentoring abilities.
• Vendor and contractor management experience.
• Financial awareness, including project cost development and budget support.
• Negotiation, conflict resolution, and facilitation skills.
• Technical presentation and communication skills.
• Strong organizational and time management skills.
• Ability to independently evaluate technical challenges and determine when additional internal or external resources are required.
• Demonstrated expertise in multiple engineering disciplines or technical areas.