Senior Process Engineer - Assembly & Devices (C&Q)

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 95,000 - 130,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks an experienced engineer to lead commissioning and qualification (C&Q) programs within pharma/biotech operations, capital projects, and pilot plants. You will design, execute, and oversee system qualifications (IQ/OQ/PQ) and ensure GMP/GLP compliance.

Responsibilities include developing C&Q strategies, coordinating vendors, and mentoring teams while maintaining schedules, budgets, and documentation integrity across complex projects.

Qualifications

• Doctorate or master's with engineering experience, or a bachelor's in engineering with 4+ years of experience.
• Experience leading complex engineering projects and multidisciplinary teams.
• Strong knowledge of GMP, GLP, and validation processes.

Responsibilities

• Develop and implement engineering strategies for system modifications.
• Supervise engineers, associates, and technicians on projects.
• Collaborate with research, manufacturing, quality assurance, and validation to define requirements.
• Coordinate with consultants and vendors; develop budgets.
• Manage multiple projects; ensure schedule, budget, and quality constraints.

Skills

Pharma processes

Validation processes

GLP/GMP knowledge

Regulated documentation

Lab equipment operation

GMP/GLP interpretation

Engineering problem solving

Technical writing

Verbal communication

Project management

Risk assessment

Change management

Contractor/vendor management

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree in Engineering + 4 years experience

Job description

Biopharma-Consulting-Jad-Group seeks an experienced engineer to lead commissioning and qualification (C&Q) programs within pharma/biotech operations, capital projects, and pilot plants. You will design, execute, and oversee system qualifications (IQ/OQ/PQ) and ensure GMP/GLP compliance.

Responsibilities include developing C&Q strategies, coordinating vendors, and mentoring teams while maintaining schedules, budgets, and documentation integrity across complex projects.