Staff Validation Engineer

Modis; Greenville (NC); On-site; USD 69,000 - 91,000; Full time

Job summary

Modis is seeking a Staff Validation Engineer for a contract position to lead validation activities in a pharmaceutical manufacturing setting with a focus on aseptic processing and sterile manufacturing.

Responsibilities include designing and executing APS studies, developing validation documentation, and collaborating with QA, regulatory, and manufacturing teams to ensure compliance with cGMP and global requirements.

Qualifications

• 8+ years of experience in pharmaceutical or biotechnology validation.
• Strong hands-on experience with Media Fill / Aseptic Process Simulation (APS).
• Experience with sterile pharmaceutical manufacturing environments and cGMP regulatory requirements.

Responsibilities

• Lead the design, planning, and execution of Media Fill studies for aseptic manufacturing processes.
• Develop, review, and approve validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPA activities related to media fills and aseptic manufacturing.

Skills

Media Fill

Aseptic Processing

Validation Leadership

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Modis is seeking a Staff Validation Engineerour Contract position with a direct client.

Pay range: $50/hr - $66/hr on w2; The rate may be negotiable based on experience, education, geographic location, and other factors.

Title: Staff Validation Engineer

Duration: 6 months

Schedule: Monday – Friday, 8:00 AM – 5:00 PM

Job Description:

We are seeking an experienced Staff Validation Engineer to lead and support validation activities within a pharmaceutical manufacturing environment, with a strong focus on aseptic processing and sterile manufacturing.

Key Responsibilities

• Lead the design, planning, and execution of Media Fill (Aseptic Process Simulation – APS) studies for aseptic manufacturing processes.
• Develop, review, and approve validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPA activities related to media fills and aseptic manufacturing processes.
• Collaborate with Manufacturing, Quality Assurance, and Regulatory teams to ensure compliance with quality standards.
• Ensure adherence to cGMP, FDA, EMA, and applicable global regulatory requirements.
• Drive continuous improvement initiatives related to validation processes and contamination control strategies.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 8+ years of experience in pharmaceutical or biotechnology validation.
• Strong hands-on experience with Media Fill / Aseptic Process Simulation (APS).
• Experience working in sterile pharmaceutical manufacturing environments.
• Strong understanding of aseptic processing, sterility assurance, and contamination control.
• Knowledge of cGMP and pharmaceutical regulatory requirements.
• Experience preparing and reviewing validation protocols, technical reports, and risk assessments.
• Ability to independently lead complex validation projects.
• Excellent communication, documentation, and cross-functional collaboration skills.

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