As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.
You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.
Your Mission Become a key player in a
brand-new greenfield project
where you will help build, qualify, and launch state-of-the-art production and packaging lines from the ground up. This is your chance to shape an entire facility’s future in a high-growth biotech/pharma/medtech environment.
You will take part in every critical stage of bringing new systems to life:
Define technical expectations by developing
high-impact URS
and performing
comprehensive risk analyses
(FMEA, FRA)
Lead the creation and review of the
Validation Master Plan (VMP)
for newly installed equipment, utilities, and production areas
Design, write, and optimize qualification and commissioning protocols ( FAT/SAT/IQ/OQ/PQ ) for new production lines, new packaging lines, and new utilities under strict
GMP/MDR requirements
Actively participate in
FAT/SAT
at supplier sites and on-site to ensure flawless equipment delivery and readiness
Execute and document
IQ/OQ/PQ
activities to qualify all new systems and guarantee GMP-compliant startup
Collaborate closely with engineering, suppliers, and operations to bring an entire greenfield site to operational excellence
Your Profile You are motivated by large-scale challenges and the opportunity to design, qualify, and launch systems in a completely new facility.
You bring:
A degree in biotechnology, pharmaceutical sciences, process engineering, or a PharmD with an industrial focus
Solid experience in
GMP process validation
and
equipment qualification
A strong command of
Good Manufacturing Practices
#J-18808-Ljbffr
You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.
Your Mission Become a key player in a
brand-new greenfield project
where you will help build, qualify, and launch state-of-the-art production and packaging lines from the ground up. This is your chance to shape an entire facility’s future in a high-growth biotech/pharma/medtech environment.
You will take part in every critical stage of bringing new systems to life:
Define technical expectations by developing
high-impact URS
and performing
comprehensive risk analyses
(FMEA, FRA)
Lead the creation and review of the
Validation Master Plan (VMP)
for newly installed equipment, utilities, and production areas
Design, write, and optimize qualification and commissioning protocols ( FAT/SAT/IQ/OQ/PQ ) for new production lines, new packaging lines, and new utilities under strict
GMP/MDR requirements
Actively participate in
FAT/SAT
at supplier sites and on-site to ensure flawless equipment delivery and readiness
Execute and document
IQ/OQ/PQ
activities to qualify all new systems and guarantee GMP-compliant startup
Collaborate closely with engineering, suppliers, and operations to bring an entire greenfield site to operational excellence
Your Profile You are motivated by large-scale challenges and the opportunity to design, qualify, and launch systems in a completely new facility.
You bring:
A degree in biotechnology, pharmaceutical sciences, process engineering, or a PharmD with an industrial focus
Solid experience in
GMP process validation
and
equipment qualification
A strong command of
Good Manufacturing Practices
#J-18808-Ljbffr
