Validation Engineer (Media Fill)

Sterling Engineering, Inc.

Greensville, NC

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JOB DETAILS

SALARY

SKILLS

Asepsis, Biology, Biotech and Pharmaceutical, Change Control, Communication Skills, Consulting, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Manufacturing, FDA (Food and Drug Administration), FDA Requirements, Health Plan, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Operations, Microbiology, Operational Support, Problem Solving Skills, Process Validation, Quality Assurance, Quality Engineering, Quality Metrics, Record Keeping, Regulations, Regulatory Requirements, Risk Analysis, Simulation, Support Documentation, Team Player, Technical Writing, Validation Documentation, Validation Plan, Writing Skills

LOCATION

Greensville, NC

POSTED

3 days ago

Job Title: Validation Engineer (Media Fill)

Location: Greenville, NC (Onsite)
Hire Type: 6-Month Contract-to-Hire
Target Pay Rate: $65.00/hour

Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), & ESOP

Additional Benefits:

Opportunity for long-term employment through contract-to-hire conversion
Opportunity to support a leading global life sciences organization
Work within a highly regulated pharmaceutical manufacturing environment

Job Summary:

Seeking a Validation Engineer (Media Fill Validation) to support aseptic manufacturing operations with a primary focus on media fill validation (aseptic process simulation/APS) activities. This individual will be responsible for planning, executing, documenting, and supporting validation studies while ensuring compliance with cGMP, FDA, EU Annex 1, and global regulatory requirements. The ideal candidate will have hands-on experience within a sterile manufacturing environment and a strong understanding of validation lifecycle activities.

Must Have Skills:

Bachelor's degree in Engineering, Life Sciences, Microbiology, or related technical discipline
5+ years of validation experience supporting pharmaceutical manufacturing
Significant experience with media fill validation / aseptic process simulation (APS)
Sterile or aseptic manufacturing experience required
Strong understanding of:
- Media fills / aseptic process simulations
- Validation lifecycle activities (IQ/OQ/PQ)
- cGMP and FDA regulations
- EU Annex 1 requirements
- Validation documentation and technical writing
- Deviation investigations and CAPA processes

Job Duties:

Plan, execute, and document media fill (aseptic process simulation) studies.
Develop and revise validation protocols, reports, deviations, and risk assessments.
Support investigations related to media fill failures and implement corrective and preventive actions (CAPAs).
Coordinate validation activities with Manufacturing, Quality Assurance, Engineering, Microbiology, and Validation teams.
Ensure validation documentation complies with cGMP, FDA, EU Annex 1, and company quality standards.
Support change control activities and assess validation impacts related to process or equipment changes.
Participate in regulatory inspections, internal audits, and validation readiness activities.
Maintain accurate validation records and support continuous improvement initiatives within the validation program.

Qualifications:

Bachelor's degree in Engineering, Life Sciences, Microbiology, or related technical field
5+ years of validation experience in a pharmaceutical, biotechnology, or sterile manufacturing environment
Hands-on experience supporting media fill validation activities
Strong knowledge of aseptic processing and sterile manufacturing practices
Excellent technical writing, problem-solving, and communication skills
Ability to collaborate effectively with cross-functional teams

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

About the Company

Sterling Engineering, Inc.

Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:

Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.

Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.

Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

1969

WEBSITE

http://www.sterling-engineering.com

Validation Engineer (Media Fill)

Sterling Engineering, Inc.

Greensville, NC

About the Company

Sterling Engineering, Inc.

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