Senior C&Q Manager: Biopharma Equipment Validation

MMR Consulting; Portland (OR); Presencial; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Travel expense package

Descripción de la vacante

MMR Consulting is seeking an experienced C&Q Manager to oversee commissioning, qualification and validation of Fill Finish and related biopharma equipment. You will lead teams of intermediate and junior engineers, coordinate cross-functional reviews, and ensure GMP-compliant deliverables across projects in Portland and client facilities.

The role requires a strong background in life science manufacturing, cGMP, and hands-on validation execution, with leadership responsibilities and travel to

Formación

• Excellent written and spoken English is required including the preparation of technical documents in English
• 8+ years of experience in commissioning, qualification or validation of pharmaceutical/biotech systems
• Knowledge of cGMP requirements including SOPs, Change Controls, Validation
• Experience with validation projects and risk-based commissioning/qualification approaches (asset, not required)
• Experience with biotech process equipment & systems such as Fill Finish, bioreactors, chromatography, TFF, UF
• Experience with process control systems (PCS, SCADA, Historians) and building automation systems (Siemens Insight/Desigo, JCI Metasys) asset
• Experience with qualification/validation of clean utilities, ISO clean rooms, Thermal Validation asset
• Preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports
• Ability to lift 50 lbs
• Science degree or related discipline
• Ability to handle multiple projects in fast-paced environment
• Strong multi-tasking skills

Responsabilidades

• Provide technical guidance into commissioning, qualification and start-up of equipment and facilities used in life science manufacturing including Fill Finish and related systems
• Lead development of qualification deliverables during project lifecycle and define test plans
• Lead qualification processes (VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ, PQ) to ensure timely completion
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports
• Coordinate cross-functional meetings to drive project progress and decisions
• Visit construction/installation sites following safety requirements

Conocimientos

Leadership skills

Project management

Communication

Multitasking

Team leadership

Educación

Science degree or related discipline

Herramientas

PCS

SCADA

Historians

Siemens Insight/Desigo

JCI Metasys

Descripción del empleo

MMR Consulting is seeking an experienced C&Q Manager to oversee commissioning, qualification and validation of Fill Finish and related biopharma equipment. You will lead teams of intermediate and junior engineers, coordinate cross-functional reviews, and ensure GMP-compliant deliverables across projects in Portland and client facilities.

The role requires a strong background in life science manufacturing, cGMP, and hands-on validation execution, with leadership responsibilities and travel to