CQV/Manufacturing Systems

Manufacturing Systems Engineer – Onsite in North Carolina (9-12 Month Contract)

Location: Onsite in North Carolina

Duration: 9-12 months

Overview

We are seeking a Manufacturing Systems Engineer or similar technical professional to support a pharmaceutical or biotech facility in its final construction and CQV phase. The facility is scaling up manufacturing operations, and this role is critical in ensuring that execution aligns with engineering and design plans.

Responsibilities

• Review and interpret engineering and design plans for the new manufacturing space.
• verify that construction and equipment installation match the approved plans.
• Work closely with CQV teams, contractors, and site engineers to ensure adherence to specifications.
• Validate P90 forms and other technical documentation against implementation.
• Ensure compliance with cGMP, FDA, EMA, ISO and industry regulations.
• Identify and address any discrepancies between design intent and on-site execution.
• Provide technical oversight and support for the manufacturing space scale-up.
  
  

Qualifications

• Technical background in Manufacturing Engineering, Process Engineering, Mechanical Engineering, and similar.
• Experience in a CQV environment (Commissioning, Qualification, and Validation).
• Strong understanding of P&IDs, engineering schematics, and process validation.
• Familiarity with biopharma, pharmaceutical, or regulated manufacturing environments.
• Knowledge of P90 forms, risk-based assessments, and facility startup operations is a plus.
  
  

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |

Phone: 949.561.0655 | Email: satish.j@itminds.net |