Engineering (Non IT) and Research - Staff Validation Engineer

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

Benefits offered by this job

Medical Insurance

Dental and Vision Insurance

401k Contributions

Critical Illness Insurance

Voluntary Permanent Life Insurance

Accident Insurance

Other Employee Perks

Job summary

LanceSoft is seeking a Staff Validation Engineer in Greenville, NC to lead media fill studies and author validation documents for aseptic processes. The role requires 8+ years in pharmaceutical validation and a background in sterile manufacturing.

You will collaborate across Manufacturing, Quality, and Regulatory teams to uphold cGMP standards, assess risks, and drive improvements in contamination control. This is a 06+ month assignment with a competitive hourly pay.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Aseptic processing and media fill execution in sterile environments.

Responsibilities

• Lead the design and execution of media fill studies for aseptic manufacturing.
• Author and review validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPAs related to media fills.
• Partner with Manufacturing, Quality, and Regulatory teams.
• Ensure compliance with cGMP, FDA, EMA, and global regs.
• Drive continuous improvement in validation and contamination control

Skills

Aseptic processing

Media fill

cGMP

Regulatory expectations

Technical writing

Project leadership

Communication skills

Education

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

Job description

Job Description

Title: Engineering (Non IT) and Research - Staff Validation Engineer

Location: Greenville, NC 27834

Duration: 06+ months

Shift: 08hr 1st shift 40 lunch

Pay Rate: $50.00 - $66.00/Hour

What will you do?

• 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

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

Employee Benefits

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal-opportunity employer.

We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.