Process Specialist

Astrix; Virginia (MN); On-site; USD 46,838 - 53,037; Full time

Benefits offered by this job

Medical insurance

Increased interview chances via referrals

Job summary

A leading CDMO firm is seeking a Process Validation Engineer to support multi-client manufacturing operations in a regulated cGMP environment. Responsibilities include executing and documenting validation activities, writing protocols for tech transfer, and supporting process engineering. The ideal candidate will have a Bachelor's degree in Engineering and 1–3 years of experience in process validation or manufacturing support. This is a full-time position with benefits such as medical insurance.

Qualifications

• 1–3 years of experience in process validation or manufacturing support in a cGMP environment.
• CDMO experience preferred.

Responsibilities

• Execute and document process validation activities for equipment and processes.
• Write validation protocols and reports for customers in support of tech transfer.
• Review manufacturing and analytical data; support deviations and investigations.

Skills

Process validation

Engineering principles

GMP compliance

Education

Bachelor’s degree in Chemical, Mechanical, or related Engineering field

Job description

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