CQV Process Engineering Consultant

Job Title : CQV Process Engineering Consultant

Location : PA, United States

Experience : 5 - 6 Years

Employment Type : 12+ months Contract

Role Overview

We're seeking experienced and technically driven CQV Process Engineering Consultant to support a range of pharmaceutical and biotech GMP manufacturing projects across the US. This role plays a key part in strengthening front-end engineering capabilities and delivering end-to-end project support -from concept through execution.

You'll act as a technical leader , managing cross-functional teams and ensuring process systems and equipment meet design, quality, and regulatory standards.

Key Responsibilities

Serve as the on-site Process Engineering lead , reporting to the Regional or Area Manager while independently driving day-to-day technical decisions in clients' best interests.

Lead multidisciplinary teams across Process Engineering, Automation, and CQV functions through all project phases-from concept and detailed design to execution.

Provide technical leadership through Safety and Quality assessments , including PHA, HAZOP, LOPA, CIP / SIP strategy, automation integration, and GMP design reviews.

Oversee vendor collaboration , ensuring operational requirements are translated into clear User Requirements Specifications (URS) and Equipment Specifications.

Review and approve vendor design submittals to confirm alignment with industry and client standards .

Coordinate closely with Civil, Structural, HVAC, Electrical, and Construction teams to ensure alignment of design priorities and timelines.

Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) -representing the client's safety and quality interests.

Manage project budgets, documentation, and deliverables, ensuring work is completed on time and within scope.

Support CQV execution activities, ensuring process systems meet all functional and performance criteria before turnover.

Required Qualifications

5+ years of experience in Process Engineering, Manufacturing, or Technical Support within a GMP or regulated environment .

Bachelor's or Master's Degree in Mechanical, Chemical, or Electrical Engineering (or related scientific / engineering discipline).

Strong working knowledge of engineering standards (ASME, ISO, NFPA, NIST).

Proven expertise in one or more of the following :

Vaccines or Biologics Manufacturing

Single-Use Systems

Hygienic Equipment Design

CIP / Clean Utilities

Process Automation (DeltaV, PLC systems)

API or Fill-Finish Operations

Containment or Sterile Process Design

Preferred Qualifications

Experience with DeltaV or equivalent automation platforms .

Familiarity with Pull Planning / Last Planner project scheduling systems.

End-to-end project exposure-from process design through commissioning and equipment turnover.

Strong communication, leadership, and technical writing skills with the ability to coordinate effectively across teams and stakeholders.