Astrix
Our client is seeking a Process Validation Engineer to support multi-client manufacturing operations in a regulated cGMP CDMO environment. This role partners closely with Manufacturing, Engineering, and QA to ensure robust, compliant, and scalable processes across diverse customer programs.
Shift:
Monday–Friday, 8:00am–5:00pm
Pay:
$34–$38.50/hour
Responsibilities
Execute and document process validation activities (PPQ, IQ/OQ/PQ) for equipment, processes, cleaning, and utilities.
Write validation protocols and reports for customers in support of tech transfer, scale-up, and routine manufacturing.
Support process engineering activities, including defining CPPs/CQAs and maintaining validated state across multiple client products.
Author and maintain SOPs, templates, and validation documentation to ensure audit readiness.
Review manufacturing, analytical, and microbial data; support deviations, investigations, and CAPAs.
Provide technical support during client and regulatory audits.
Qualifications
Bachelor’s degree in Chemical, Mechanical, or related Engineering field.
1–3 years of experience in process validation, process engineering, or manufacturing support in a cGMP environment (CDMO experience preferred)
Seniority Level
Associate
Employment Type
Full-time
Job Function & Industries Personal Care Product Manufacturing
Benefits Medical insurance
Referrals increase your chances of interviewing at Astrix by 2x
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Shift:
Monday–Friday, 8:00am–5:00pm
Pay:
$34–$38.50/hour
Responsibilities
Execute and document process validation activities (PPQ, IQ/OQ/PQ) for equipment, processes, cleaning, and utilities.
Write validation protocols and reports for customers in support of tech transfer, scale-up, and routine manufacturing.
Support process engineering activities, including defining CPPs/CQAs and maintaining validated state across multiple client products.
Author and maintain SOPs, templates, and validation documentation to ensure audit readiness.
Review manufacturing, analytical, and microbial data; support deviations, investigations, and CAPAs.
Provide technical support during client and regulatory audits.
Qualifications
Bachelor’s degree in Chemical, Mechanical, or related Engineering field.
1–3 years of experience in process validation, process engineering, or manufacturing support in a cGMP environment (CDMO experience preferred)
Seniority Level
Associate
Employment Type
Full-time
Job Function & Industries Personal Care Product Manufacturing
Benefits Medical insurance
Referrals increase your chances of interviewing at Astrix by 2x
#J-18808-Ljbffr