Biopharma C&Q Lead: Commissioning & Qualification Manager

MMR Consulting; Tijuana; Presencial; MXN 1.100.000 - 1.400.000; Jornada completa

Descripción de la vacante

MMR Consulting, an engineering and consulting firm in the pharmaceutical and biotechnology industries, seeks a C&Q Manager to lead validation of bioprocess systems and equipment.

The successful candidate will direct commissioning, qualification, and start-up activities, coordinating with engineers and clients while ensuring GMP compliance and timely project delivery. US client sites may require occasional travel and visa sponsorship considerations.

Formación

• 8+ years in commissioning, qualification or validation in pharma/biotech.
• GMP knowledge including SOPs, Change Controls, Validation.
• Experience with VPP, RTM, IQ/OQ/PQ, FAT/SAT.

Responsabilidades

• Provide technical guidance into commissioning, qualification, and start-up of equipment and facilities used in life science manufacturing.
• Lead the development of qualification deliverables to ensure the project is well defined and tested.
• Leadqualification processes throughout the project lifecycle including VPP, RTM, DQ, FAT, SAT, IQ, OQ, and PQ as appropriate.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of upstream or downstream bioprocess systems is required; exposure to other process equipment is an asset.
• Coordinate meetings with cross-functional departments to drive project progress and decisions.
• Travel occasionally for meetings with clients, vendors, or FATs.
• Support proposals and business development with technical input.

Conocimientos

Leadership

Project management

Team leadership

Multitasking

Fast-paced environment adaptability

Educación

Engineering or science degree

Herramientas

PCS/SCADA

Historian

Siemens Insight

Desigo

Descripción del empleo

MMR Consulting, an engineering and consulting firm in the pharmaceutical and biotechnology industries, seeks a C&Q Manager to lead validation of bioprocess systems and equipment.

The successful candidate will direct commissioning, qualification, and start-up activities, coordinating with engineers and clients while ensuring GMP compliance and timely project delivery. US client sites may require occasional travel and visa sponsorship considerations.