To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepakarya8a79aa22a/), email your updated resume at Email deeparya@collabera.com. Thank you!

Pay Range: $30 to $35 an hour

Client Industry: Medical Device

Job Mode: Onsite

Contract Duration: 09 Months (Possibilities of Extension)

Job Summary:

We are seeking a Validation Engineer to support validation activities within a regulated manufacturing and quality systems environment. This role is responsible for developing, executing, and maintaining validation documentation for systems, equipment, and manufacturing processes. The candidate will collaborate with cross functional teams to ensure compliance with regulatory and internal quality standards. The position requires strong technical writing, analytical problem solving, and validation execution experience within regulated industries. This opportunity is ideal for professionals experienced in validation engineering, process controls, and quality compliance activities.

Key Responsibilities:

• Develop and maintain validation documentation for manufacturing systems and production processes.
• Execute validation protocols and support IQ OQ PQ activities for equipment and systems.
• Review validation data and prepare detailed validation summary reports.
• Support validation assessments related to process changes, system updates, and document revisions.
• Collaborate with Quality, Engineering, Manufacturing, and Regulatory teams to ensure validation compliance.
• Support internal and external audits by maintaining validation and documentation accuracy.
• Track validation project progress and maintain validation status reporting tools.
• Assist with Validation Master Plan maintenance and validation lifecycle activities.
• Provide guidance to junior team members and support continuous process improvement initiatives.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related technical discipline.
• Minimum 2 years of validation or quality engineering experience in a regulated environment.
• Experience supporting IQ OQ PQ validation activities.
• Knowledge of FDA regulations, GMP, and quality systems requirements.
• Strong technical writing and documentation skills.
• Experience with change control, root cause analysis, and compliance activities.
• Ability to work effectively with cross functional teams in manufacturing environments.

Preferred Qualifications:

• Master’s degree in a related technical discipline.
• Experience in medical device or pharmaceutical manufacturing industries.
• Knowledge of Validation Master Plans and process validation methodologies.
• Experience supporting audits and regulatory inspections.
• Exposure to CAPA, NCR, and risk management processes.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, longterm disability insurance, shortterm disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)