Staff Engineer, MSAT Validation

Description

The company supplies tools and services to science and reports annual revenue above $40 billion.

This role sits in sterile and aseptic manufacturing. You will lead validation work for processes, cleaning, and media fill (aseptic process simulation) programs to keep systems in a validated state and support compliant production.

Depending on business needs, you may cover process validation, cleaning validation, or media fill/aseptic process simulation. You will give technical direction on complex validation work and work across functions in a sterile plant.

Responsibilities

• Lead or support PPQ, cleaning validation, and media fill work for sterile and aseptic processes.
• Build validation strategies for new and current products, processes, and cleaning methods using lifecycle and risk-based thinking.
• Write and run validation protocols and reports, plus risk assessments and other technical records.
• Analyze data and assess technical findings to back validation conclusions and maintain the validated state.
• Take part in investigations, deviations, change controls, and CAPAs tied to validation and aseptic work.
• Work with Manufacturing, Quality, MS&T, and Regulatory to deliver validation programs.
• Make sure validation aligns with cGMP and global rules, including FDA and EMA expectations.
• Help with internal and external audits and inspections, and improve validation and contamination control approaches over time.

Requirements

• Bachelor's degree in engineering, chemistry, life sciences, or a related field.
• At least 8 years in pharmaceutical or biotechnology validation.
• Experience in sterile or aseptic manufacturing is required.
• Strong experience in at least one of: process validation (PPQ), cleaning validation, or media fill/aseptic process simulation.
• Experience with validation lifecycle work and risk-based approaches.
• Solid grasp of aseptic processing, contamination control, and validated-state principles.
• Strong knowledge of cGMP and related regulatory requirements.
• Skilled technical writer for protocols and reports.
• Data analysis, technical assessment, and problem-solving skills.
• Able to lead complex validation projects on your own and juggle several priorities.
• Good cross-functional collaboration, communication, and stakeholder management.
• Able to support audits, inspections, investigations, deviations, change controls, and CAPAs.
• You must be legally authorized to work in the United States without sponsorship.

Conditions

Location: Greenville, NC.

Standard Monday to Friday schedule.

Lab setting with loud equipment noise, strong chemical, lubricant, and biological odors, and hazardous or toxic materials.

Lifting up to 40 lbs without help, following GMP safety standards, and wearing some PPE such as safety glasses, gowning, gloves, lab coats, and ear plugs.

The listed duties are not a complete list of the work.

Benefits

• Competitive wages.
• Medical, dental, and vision coverage starting day 1.
• Paid time off and holidays.
• 401(k) company match up to 6%, after 1 year.
• Tuition reimbursement after 90 days.
• Employee referral bonus.
• Employee discount program.
• Recognition program.
• Charitable gift matching.
• Paid parental leave.
• Company supplies computer, monitor, keyboard, and mouse.
• Company provides PPE such as lab coats, safety glasses, and safety shoes.