Senior Process Engineer – Pharma Manufacturing

Quality Consulting Group, LLC; Juncos (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Quality Consulting Group, LLC is seeking an experienced engineering professional to join our team in Puerto Rico & USA. You will contribute in a world-class manufacturing industry, leading process optimization, troubleshooting, and capital project initiatives within a highly regulated environment.

The role demands strong analytical, technical writing, and cross-functional collaboration skills to develop guidelines, evaluate equipment, and support deviations and CAPAs.

Qualifications

• Must have a bachelor’s degree in engineering.
• Experience performing technical assessments of equipment in a regulated pharmaceutical, biotechnology, or manufacturing environment.
• Experience preparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Demonstrated ability to evaluate equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to product quality.
• Experience providing technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitment activities.
• Knowledge of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
• Strong technical writing skills.
• Experience collaborating cross-functionally with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to gather and evaluate technical information.
• Working knowledge of cGMP requirements and ability to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.

Responsabilités

• Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.

Connaissances

Analytical skills

Problem solving

Communication skills

Technical writing

Cross-functional collaboration

Attention to detail

Project coordination

Cgmp knowledge

Formation

Bachelor’s degree in Engineering

Description du poste

Quality Consulting Group, LLC is seeking an experienced engineering professional to join our team in Puerto Rico & USA. You will contribute in a world-class manufacturing industry, leading process optimization, troubleshooting, and capital project initiatives within a highly regulated environment.

The role demands strong analytical, technical writing, and cross-functional collaboration skills to develop guidelines, evaluate equipment, and support deviations and CAPAs.