Validation Engineer

Hi

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Validation Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: Validation Engineer
Location: Massachusetts
Duration: Long Term

Position Overview

We are seeking an experienced Validation Engineer to support qualification and validation activities within a pharmaceutical manufacturing environment. This role will focus on equipment qualification process validation cleaning validation computerized system validation documentation review and compliance with FDA and cGMP requirements. The ideal candidate will work closely with Manufacturing Engineering Quality Assurance and Regulatory teams to ensure validated systems remain compliant and inspection-ready.

Key Responsibilities

Develop execute and review validation protocols and reports including IQ OQ PQ and requalification activities.
Support equipment utility facility process and cleaning validation programs.
Prepare and maintain validation documentation in accordance with cGMP and regulatory requirements.
Coordinate validation activities with Manufacturing Engineering Quality Assurance and project teams.
Perform risk assessments and gap analyses to identify validation and compliance requirements.
Investigate validation deviations implement corrective actions and support CAPA activities.
Ensure validation lifecycle activities comply with FDA regulations 21 CFR Part 210/211 and industry standards.
Support commissioning and qualification activities for new equipment facilities and manufacturing processes.
Participate in audits inspections and validation-related regulatory submissions.
Contribute to continuous improvement initiatives to enhance validation processes and compliance.

Required Qualifications

Bachelors Degree in Engineering Pharmaceutical Sciences Biotechnology Chemistry Life Sciences or a related technical discipline.
3 7 years of Validation Engineering experience within pharmaceutical biotechnology medical device or regulated manufacturing environments.
Strong experience with equipment qualification (IQ/OQ/PQ) process validation and validation lifecycle management.
Knowledge of cGMP regulations FDA requirements data integrity principles and validation industry standards.
Experience supporting cleaning validation computerized system validation (CSV) or utility validation is preferred.
Familiarity with risk assessments deviation investigations CAPA and change control processes.
Strong technical writing documentation analytical and problem-solving skills.
Ability to manage multiple validation projects and work effectively in a cross-functional environment.
Experience supporting regulatory inspections and audit readiness activities is highly preferred.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions please send me your updated resume along with the best number and time to reach you.

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