Tittle: Engineer – PRQN 769
Location: Juncos, Puerto Rico
Work Schedule: On-site | Administrative Shift
Shift Flexibility: Must be available to work different shifts and/or weekends based on business needs
Positions Available: 1
Contract Duration: 6 months
Important Notice
This opportunity is available only to direct individual candidates. Third-party contractors, staffing agencies, vendors, and Corp-to-Corp (C2C) arrangements will not be considered.
Position Summary
Our client is seeking an Engineer to support process characterization, optimization strategies, operational troubleshooting, equipment reliability, and engineering projects within a manufacturing, operations, pilot plant, or capital projects environment.
Under general supervision, this professional will apply fundamental engineering principles to support system modifications, experiments, equipment improvements, and capital projects. The role will also involve analyzing operational issues, interpreting results, supporting compliance activities, and developing solutions to technical problems of moderate scope and complexity.
Key Responsibilities
Engineering & Operations
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
- Perform assignments with clearly defined objectives that require investigation of a limited number of variables.
- Initiate and complete routine technical engineering tasks.
- Support process characterization, optimization initiatives, troubleshooting, and operational improvement activities.
- Apply engineering principles and science to support manufacturing and production operations.
- Develop solutions to routine technical problems within the assigned area of responsibility.
Manufacturing Equipment & Reliability
- Own manufacturing equipment within the CMMS system, including:
- Work order approval and closure.
- Preventive maintenance (PM) strategy.
- Spare parts definition, accuracy, and updates.
- Reliability assessments.
- Change control assessments and requirements.
- Collaborate with Engineering staff to establish effective maintenance strategies for manufacturing equipment.
- Enhance system reliability by improving equipment availability, reducing downtime, and optimizing maintenance activities.
- Develop equipment performance metrics, including availability and downtime, to identify opportunities for improvement.
- Lead the implementation of equipment improvement projects.
- Serve as a Subject Matter Expert (SME) for assigned equipment and systems, including design, maintenance, and compliance-related activities.
- Support equipment troubleshooting within the functional area or assigned technical area of expertise.
Cross-Functional Collaboration
- Work closely with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for system modifications.
- Participate in daily operations when needed to meet schedules or resolve complex technical issues.
- Support engineering and manufacturing teams in identifying and implementing equipment and process improvements.
Design Engineering & Projects
- Work under the direction of Project Managers to complete design, engineering, and construction projects within established schedules and budget constraints.
- Collaborate with consultants, architects, and engineering firms in developing standard design documentation.
- Obtain and evaluate quotes for equipment modifications and installations.
- Develop basic project cost estimates and schedules.
- Support equipment improvement and capital projects from development through implementation.
Quality, Compliance & Safety
- Routinely audit the operational performance and regulatory compliance of assigned equipment and systems.
- Support the deviation process and define, implement, and own CAPAs associated with equipment within the assigned area of expertise.
- Apply and interpret applicable Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Support validation activities and demonstrate an understanding of validation protocol execution requirements.
- Drive Environmental, Health, and Safety (EHS) compliance within the organization.
- Prepare technical documentation, reports, and presentations related to engineering activities and projects.
Education & Experience
Required:
- Master's degree OR
- Bachelor's degree in Engineering with at least 2 years of engineering experience.
Preferred Qualifications
- Working knowledge of pharmaceutical or biotechnology manufacturing processes.
- Familiarity with validation processes and validation protocol execution.
- Experience with documentation within a highly regulated environment.
- Ability to operate specialized laboratory equipment and computer systems, as applicable.
- Ability to interpret and apply GLP and GMP requirements.
- Understanding of engineering principles as applied to production and manufacturing environments.
- Experience with equipment troubleshooting, reliability, and maintenance strategies.
- Experience with CMMS systems and manufacturing equipment ownership.
- Ability to support deviation investigations and CAPA implementation.
- Strong analytical and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to prepare basic technical reports and presentations.
- Familiarity with validation protocol writing.
- Strong organizational and time-management skills.
- Ability to adapt to and manage change effectively.
- Technical knowledge related to assigned equipment and systems.
- Computer literacy and ability to work with relevant engineering and business systems.
Key Skills
- Engineering & Applied Problem Solving
- Manufacturing Equipment Reliability
- CMMS / Maintenance Systems
- Equipment Troubleshooting
- Preventive Maintenance Strategy
- Equipment Performance Metrics
- Downtime Reduction
- Maintenance Optimization
- Equipment Improvement Projects
- Change Control
- Deviations & CAPAs
- GMP / GLP
- Validation
- Technical Documentation
- Project Support
- Technical Report Writing
- Technical Presentations
- Cross-Functional Collaboration
- Environmental, Health & Safety (EHS) Compliance