MV01-031626 Senior Validation Specialist (OSD)

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Senior Validation Specialist – Oral Solid Dosage

Description:

Validation professional with 8+ years of experience in pharmaceutical manufacturing, specializing in oral solid dosage processes (tablets and capsules). Responsible for supporting validation activities in a GMP-regulated environment and able to work independently with minimal supervision.

Responsibilities:

• Execute process validation activities for oral solid dosage manufacturing processes (tablets and capsules).
• Develop and execute validation protocols and reports in compliance with cGMP requirements.
• Support process performance qualification (PPQ) and validation lifecycle activities.
• Collaborate with Manufacturing, Quality, and Engineering teams to ensure successful validation execution.
• Assist with deviation investigations, change controls, and documentation updates related to validation activities.
• Provide technical support during process troubleshooting and validation studies.

Qualifications:

• Bachelor's Degree in Engineering or Science.
• Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.