Overview
Validation Engineer Jobs in Springfield, MA at Stark Pharma Solutions Inc
Title: Validation Engineer
Company: Stark Pharma Solutions Inc
Location: Springfield, MA
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
Bachelor's 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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