E&D Support - Media Prep and LV
Springhouse PA.
Background / Experience:
- Engineering degree(Mechanical Chemical Bioprocess or related field).
- 510 years of experiencein biotech pharmaceutical or life sciences manufacturing projects.
- Strong background inprocess equipment design and integration especially inmedia prepandviral vector (lentivirus) support areas.
- Hands-on experience withcGMP facilitiesand regulatory compliance (FDA EMA ICH guidelines).
- Proven track record inmanaging full project lifecycle from design fabrication and installation through start-up and CQV handover.
- Experience working withAE firms owner reps and cross-functional teams(process engineering validation automation operations).
Technical Skills:
- Knowledge ofbioprocessing equipment(bioreactors filtration mixing/skid systems chromatography etc.).
- Familiarity withmedia prep workflowsandviral vector handlingrequirements.
- Strong understanding ofcleanroom design utilities and process support systems.
- Proficiency intechnical documentation URS/FS/DQ/IQ/OQ and change control processes.
- Ability to manageintegration of automation controls and facility systems.
Soft Skills / Attributes:
- Strongproject managementandcoordination skills.
- Excellent communication able to work withcross-disciplinary stakeholders.
- Detail-oriented with the ability tobalance design integrity with project timelines.
- Problem-solving mindset with focus onscalability reliability and efficiency.
E&D Support - Media Prep and LV Springhouse PA. Background / Experience: Engineering degree(Mechanical Chemical Bioprocess or related field). 510 years of experiencein biotech pharmaceutical or life sciences manufacturing projects. Strong background inprocess equipment design and integration espec...
E&D Support - Media Prep and LV
Springhouse PA.
Background / Experience:
- Engineering degree(Mechanical Chemical Bioprocess or related field).
- 510 years of experiencein biotech pharmaceutical or life sciences manufacturing projects.
- Strong background inprocess equipment design and integration especially inmedia prepandviral vector (lentivirus) support areas.
- Hands-on experience withcGMP facilitiesand regulatory compliance (FDA EMA ICH guidelines).
- Proven track record inmanaging full project lifecycle from design fabrication and installation through start-up and CQV handover.
- Experience working withAE firms owner reps and cross-functional teams(process engineering validation automation operations).
Technical Skills:
- Knowledge ofbioprocessing equipment(bioreactors filtration mixing/skid systems chromatography etc.).
- Familiarity withmedia prep workflowsandviral vector handlingrequirements.
- Strong understanding ofcleanroom design utilities and process support systems.
- Proficiency intechnical documentation URS/FS/DQ/IQ/OQ and change control processes.
- Ability to manageintegration of automation controls and facility systems.
Soft Skills / Attributes:
- Strongproject managementandcoordination skills.
- Excellent communication able to work withcross-disciplinary stakeholders.
- Detail-oriented with the ability tobalance design integrity with project timelines.
- Problem-solving mindset with focus onscalability reliability and efficiency.
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