Engineer
BioPharma Consulting JAD Group Ver todas las vacantes
- Juncos, PR
- Autónomo
- Tiempo completo
- Provide solutions to technical problems of moderate scope and complexity
- Evaluate, select, and apply standard engineering techniques and procedures
- Execute assignments with defined objectives and limited variables
- Initiate and complete routine technical and engineering tasks
- Analyze and present data to support operational improvements and project outcomes
- Serve as a technical expert for troubleshooting equipment and system issues
- Support daily manufacturing operations to meet production schedules and resolve issues
- Audit operational performance and ensure compliance of equipment and systems
- Collaborate with cross-functional teams (Manufacturing, Maintenance, Quality, Validation, Facilities, Utilities, Process Development)
- Develop and implement recommendations for system and process improvements
- Support project managers in executing design, engineering, and construction projects
- Assist in delivering projects within scope, schedule, and budget
- Collaborate with external consultants, architects, and engineering firms
- Review and evaluate vendor quotes for equipment modifications and installations
- Develop basic cost estimates and project schedules
- Own manufacturing equipment within CMMS systems (work orders, PM strategy, spare parts management)
- Enhance system reliability by improving equipment availability and reducing downtime
- Develop and track equipment performance metrics (e.g., uptime, downtime, efficiency)
- Lead equipment improvement and optimization projects
- Act as Subject Matter Expert (SME) for assigned systems (design, maintenance, compliance)
- Support troubleshooting and technical investigations within area of expertise
- Drive maintenance optimization strategies in collaboration with engineering teams
- Support deviation investigations and implement CAPAs related to equipment and systems
- Participate in change control activities and impact assessments
- Ensure compliance with GMP/GLP and internal quality standards
- Promote and support Environmental, Health, and Safety (EHS) initiatives
- Strong analytical problem-solving and troubleshooting skills
- Applied engineering and technical decision-making
- Basic technical report writing and documentation skills
- Effective verbal communication and cross-functional collaboration
- Validation protocol execution understanding
- Organizational and time management skills
- Adaptability and change management
- Equipment-specific technical expertise
- Computer literacy (e.g., CMMS, MS Office)
- Ability to support technical presentations and reporting
- Master's degree in Engineering, OR
- Bachelor's degree in Engineering + 2 years of relevant experience
- Working knowledge of pharmaceutical or biotechnology manufacturing processes
- Experience with validation processes (IQ/OQ/PQ)
- Familiarity with regulated environments (GMP/GLP) and technical documentation
- Experience with CMMS systems and equipment lifecycle management
- Knowledge of reliability engineering and maintenance strategies
- Experience with deviation management, CAPA, and change control
- Administrative Shift
- 6-month contract