Validation Analyst (Lab X)

Role & Responsibilities

Looking for a person who knows Lab X to handle rollout and ensure instruments are fully operational.

• Key Responsibilities{​{:}

• }Instrument Rollout & Complianc

e
• For Lab X - Deploy instruments, ensure functionality, and validate connection
s
• Work in gowning & process area
s
• Follow GxP, pharma/biotech regulations, and ALCOA principle
s

• Software & IT Aspect

s
• System administration, and user access control
s
• Software rollout and data integrity considerations (data types, file types, software-database connections
)
• Network & domain configuration
s

• Validation & Documentatio

n
• Equipment validation & troubleshootin
g
• Work with ValGenesi
s
• Heavy documentation responsibility, working alongside Software SME
s
• IOQ, vendor coordination, preliminary and full PQ with Manufacturing & QC before release to productio
n

• Training & Suppor

t
• Train Manufacturing & QC teams on device usag
e
• Conduct working session
s

Job Requirement

• s Experience in{​{:

}
• } GxP compliance, pharma/biote
c
• h IT knowledge—networking, system configurations, troubleshooti
n
• g Software administration and validati
o
• n Equipment validation processes (IOQ, PQ, vendor coordinatio
n
• ) Strong documentation skil
l
• s Knowledge of Lab X software
.

• ts Experience in{​{

:
• }} GxP compliance, pharma/biot
e
• ch IT knowledge—networking, system configurations, troubleshoot
i
• ng Software administration and validat
i
• on Equipment validation processes (IOQ, PQ, vendor coordinati
o
• n) Strong documentation ski
l
• ls Knowledge of Lab X softwa