What are the responsibilities and job description for the Process Specialist position at 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
What You'll Do
- 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.
What You Bring
- 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)
Salary : $34 - $39