Manufacturing Process Engineer – Nights & Weekends

ProQuality Network; Juncos (PR); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

ProQuality Network in Puerto Rico is seeking an Engineer to provide technical support to continuous daily manufacturing operations. This role will focus on equipment and process troubleshooting, process optimization, system modifications, upgrades, replacements, and engineering support within a regulated manufacturing environment.

The selected candidate will work under general supervision to apply engineering principles to resolve operational issues, support manufacturing activities, and

Qualifications

• Bachelor’s degree in Engineering with at least 2 years of engineering experience.
• Background in pharmaceutical or biotech processes and GMP manufacturing.
• Ability to work onsite with non-standard shifts.

Responsabilités

• Provide engineering solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques to resolve operational issues.
• Support equipment and process troubleshooting during daily manufacturing operations.
• Function as a technical resource for processes, equipment, and systems during troubleshooting activities and cross-functional discussions.
• Become actively involved in manufacturing operations when needed to maintain schedules or resolve complex technical issues.
• Monitor manufacturing processes and equipment performance, identify issues, recommend solutions, and provide troubleshooting support.
• Develop and support process optimization strategies, equipment upgrades, replacements, and system or process modifications.
• Work collaboratively with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for process and system modifications.
• Support the execution of manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and New Product Introduction (NPI) activities.
• Apply engineering, scientific, operational, analytical, and troubleshooting knowledge to support manufacturing operations.
• Organize, analyze, and present results related to operational issues and engineering projects.
• Apply basic engineering principles to the design and implementation of system modifications, experiments, and capital projects.
• Support routine technical assignments involving investigation and evaluation of a defined number of variables.
• Assist with engineering projects, including design activities, technical evaluations, equipment modifications, and project documentation.
• Work with consultants, architects, and engineering firms when required to support engineering and design activities.
• Review and provide technical input on quotes for equipment modifications or installations.
• Assist with developing basic project cost estimates and schedules.
• Ensure engineering and manufacturing activities are performed in compliance with GMPs, applicable regulatory requirements, and established company procedures.
• Support 24/7 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as business needs require.

Connaissances

GMP knowledge

Validation experience

Technical writing

Cross-functional

English/Spanish

Formation

Bachelor’s degree in Engineering

Description du poste

ProQuality Network in Puerto Rico is seeking an Engineer to provide technical support to continuous daily manufacturing operations. This role will focus on equipment and process troubleshooting, process optimization, system modifications, upgrades, replacements, and engineering support within a regulated manufacturing environment.

The selected candidate will work under general supervision to apply engineering principles to resolve operational issues, support manufacturing activities, and