Validation Engineer

Modis; Greenville (NC); On-site; USD 83,000 - 91,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Short-term disability

401K plan

Job summary

Modis in Greenville, NC seeks a Staff Validation Engineer to lead aseptic validation initiatives. The role focuses on media fills, aseptic processing, and regulatory-compliant validation documentation, with collaboration across Manufacturing, Quality, and Regulatory teams.

The ideal candidate has 8+ years in pharmaceutical/biotech validation, strong technical writing skills, and proven ability to manage complex validation projects independently, in a GMP environment.

Qualifications

• Bachelors degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Strong experience with aseptic processing and media fill execution (required).
• Experience in sterile manufacturing environments (required).
• Deep understanding of aseptic processing and contamination control.
• Strong knowledge of cGMP and regulatory expectations.
• Technical writing expertise (validation protocols and reports).
• Ability to lead complex validation projects independently.
• Strong collaboration and communication skills.

Responsibilities

• Lead the design and execution of media fill (APS) studies for aseptic manufacturing processes.
• Author and review validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPAs related to media fills and aseptic processes.
• Partner cross-functionally with Manufacturing, Quality, and Regulatory teams.
• Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements.
• Drive continuous improvement initiatives in validation and contamination control strategies.

Skills

Aseptic processing

Media fill execution

Sterile manufacturing

cGMP knowledge

Regulatory expectations

Technical writing

Project leadership

Collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Modis is seeking Staff Validation Engineer role in Greenville, NC. Ideally, looking for someone with 8+ years of experience in pharmaceutical/biotech validation.

Rate Range: $60/hour to $66/hour on w2. The rate may be negotiable based on experience, education, geographic location, and other factors.

JOB RESPONSIBILITIES

• Lead the design and execution of media fill (APS) studies for aseptic manufacturing processes.
• Author and review validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPAs related to media fills and aseptic processes.
• Partner cross-functionally with Manufacturing, Quality, and Regulatory teams.
• Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements.
• Drive continuous improvement initiatives in validation and contamination control strategies.

QUALIFICATIONS

• Bachelors degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Strong experience with aseptic processing and media fill execution (required).
• Experience in sterile manufacturing environments (required).
• Deep understanding of aseptic processing and contamination control.
• Strong knowledge of cGMP and regulatory expectations.
• Technical writing expertise (validation protocols and reports).
• Ability to lead complex validation projects independently.
• Strong collaboration and communication skills.

If you have questions about the position, please contact Mohammed Irfan Murtuza at [e-mail]

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers