Staff Validation Engineer

Integrated Resources, Inc ( IRI ); Greenville (NC); On-site; USD 69,000 - 91,000; Full time

Job summary

Integrated Resources, Inc. seeks a senior validation specialist to lead media fill studies for aseptic manufacturing, author validation docs, and drive improvements across cGMP processes.

You will collaborate with Manufacturing, Quality, and Regulatory teams to ensure regulatory compliance and robust validation strategies. The successful candidate has 8+ years in pharma/biotech validation, strong aseptic processing experience, and proven technical writing skills to produce protocols and reports

Qualifications

• Bachelor’s 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.
• Experience in sterile manufacturing environments.
• Deep understanding of aseptic processing and contamination control.
• Strong knowledge of cGMP and regulatory expectations.
• Technical writing expertise in 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 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

Collaboration skills

Communication skills

Technical writing

Project leadership

cGMP knowledge

Regulatory knowledge

Aseptic processing

Media fill execution

Sterile manufacturing

Education

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

Job description

Duration: 6months W2 contract with high possibility of extension based on performance and depending on business needs

Pay Range: $50 to $66/Hour on W2

Description: What will you do?

Lead the design and execution of media fill (Client) 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

Education:

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

Experience:

8+ years of experience in pharmaceutical/biotech validation

Strong experience with aseptic processing and media fill execution (required)

Experience in sterile manufacturing environments (required)

Knowledge, Skills, Abilities:

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