Junior Validation Engineer

Junior Validation Engineer at Novozen Healthcare LLC Junior Validation Engineer at Novozen Healthcare LLC in NORTH WALTHAM, Massachusetts Posted in about 4 hours ago.

Type:

full-time

Job Description:

Job Title :

Junior Validation Engineer Location :

Boston, MA Employment Type :

Contract ( W2 )

Duration :

6-12 Months About the Role We are seeking a Junior Validation Engineer with experience in medical device or pharmaceutical manufacturing environments to support validation and qualification activities within a regulated GMP setting. This role will work closely with Quality, Manufacturing, and Engineering teams to execute validation protocols, maintain compliance documentation, and support ongoing process improvement initiatives. Responsibilities

• Support execution of equipment, process, cleaning, and software validation activities
• Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
• Prepare, review, and maintain validation documentation and reports
• Support deviation investigations, CAPA activities, and change control processes
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality procedures
• Collaborate with Manufacturing, Quality Assurance, and Engineering teams during validation activities
• Assist in risk assessments, root cause analysis, and continuous improvement initiatives
• Support audit readiness and inspection activities as needed Required Qualifications
• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical field
• Minimum 2 years of validation experience in Medical Device or Pharmaceutical industries
• Hands-on experience with

IQ/OQ/PQ

activities and validation lifecycle documentation

• Understanding of c

GMP, FDA

regulations, and quality systems

• Strong technical documentation and communication skills
• Ability to work effectively within cross-functional teams Preferred Qualifications
• Experience with process validation, cleaning validation, or sterilization validation
• Familiarity with CAPA, deviations, and change control systems
• Experience with validation protocols in GMP-regulated manufacturing environments
• Knowledge of statistical tools and risk management methodologies Salary The hourly rate/salary for this position is based on experience.

Benefits Benefits will be provided by the hiring client in accordance with their policies. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background Check Background checks may be conducted in accordance with applicable laws Work Authorization Applicants must be authorized to work in the United States