Design Verification Lead Consultant

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Design Verification Lead Consultant position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Design Verification Lead Consultant

Location: Huntsville, AL / Richmond, VA

Duration: Long Term

Overview

Seeking an experienced Design Verification Lead to support a new pharmaceutical drug substance manufacturing facility buildout. This hands-on role will lead design verification activities for facilities, utilities, equipment, automation systems, and processes to ensure compliance with GMP and regulatory requirements.

Key Responsibilities

Lead Design Verification (DV) activities across facility and process systems.

Review P&IDs line-by-line and verify design intent.

Develop and review URS, DV plans, protocols, reports, traceability matrices, and risk assessments.

Support facility design from pre-concept through commissioning and startup.

Review vendor FDS, DDS, and engineering documentation.

Manage change controls, FAT/SAT alignment, and commissioning support.

Evaluate material flow, personnel flow, and warehouse operations.

Collaborate with Engineering, Quality, Validation, Manufacturing, and vendors.

Requirements

• Strong pharmaceutical CAPEX and facility buildout experience.

• Expertise in Design Verification, P&IDs, URS development, and GMP compliance.

• Experience with FDA, EMA, ICH Q8-Q11, and ISPE guidelines.

• Proven background supporting greenfield or site expansion projects.

• Experience with risk assessments, change control, commissioning, and qualification activities.

• 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.

• Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

• Thank you,

• Karthik Mutyala

• Recruiting Manager

• Stark Pharma Solutions Inc

• Email: karthik@starkpharma.com

• 15 Corporate Place S, Suite 350,

• Piscataway, New Jersey 08854

• www.starkpharma.com