Project Engineer CQ Pharma GMP

Tekhawks LLC

Indianapolis (IN)

On-site

USD 110,000 - 140,000

Full time

5 days ago
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Job summary

Tekhawks LLC in Indianapolis, IN is seeking a Project Engineer with a strong Commissioning & Qualification background to support a large peptide manufacturing project on-site.

You will own project scopes, drive meetings, coordinate stakeholders, review engineering designs, and ensure deliverables are completed to schedule. The role demands hands-on experience in GMP capital projects and ability to thrive in an active construction environment.

Qualifications

  • 7+ years of engineering, C&Q, commissioning, validation, or capital project experience.
  • Strong C&Q background with API or peptide manufacturing exposure.
  • Experience on large-scale pharmaceutical capital projects.
  • Experience with engineering design reviews and redlining.
  • Experience coordinating contractors, vendors, and cross-functional teams.
  • Ability to own project scopes and drive them to completion.
  • Excellent communication and meeting leadership skills.
  • Field/active construction environment experience.

Responsibilities

  • Serve as right hand to the Node Lead for the Peptide 1 Building.
  • Act as extension of project leadership and support day-to-day execution.
  • Own assigned mini-projects, technical scopes, and deliverables.
  • Drive project meetings and coordinate cross-functional stakeholders.
  • Review, redline, and approve engineering designs and technical docs.
  • Coordinate with Engineering, C&Q, Construction, Operations, Quality, and vendors.
  • Support commissioning and qualification activities throughout the lifecycle.
  • Track project progress, risks, actions, and milestones.
  • Coordinate contractors and vendors supporting scopes.
  • Participate in design reviews, field walkdowns, and construction coordination.
  • Assist with system turnover, commissioning, startup, and operational readiness.

Skills

C&Q
Project engineering
API/peptide manufacturing
GMP capital projects
engineering design review
construction coordination
commissioning
qualification
contractor management
ownership of project scope
cross-functional leadership

Job description

Job Description

Job Description

** Position: Project Engineer – C+Q**

** Location: Indianapolis, IN (100% Onsite)**

** Duration: 12+ months with possibility of extension**

** Hours per week: 40 initially; schedule expected to increase in Q2**

Job Description:

Our client is seeking an experienced Project Engineer with a strong Commissioning & Qualification (C&Q) background to support a large-scale peptide manufacturing project. This individual will serve as the right hand to the Node Lead for the Peptide 1 Building and act as an extension of the project leadership team.

The Project Engineer will take ownership of assigned project scopes and mini-projects, drive meetings, coordinate stakeholders, review and redline engineering designs, and ensure assigned deliverables are completed successfully. The ideal candidate will have experience supporting large-scale pharmaceutical capital projects, with API or peptide manufacturing experience strongly preferred.

** Responsibilities**

  • Serve as the right hand to the Node Lead for the Peptide 1 Building
  • Act as an extension of project leadership and support day-to-day project execution
  • Own assigned mini-projects, technical scopes, and deliverables through completion
  • Drive project meetings and coordinate cross-functional stakeholders
  • Review, redline, and approve engineering designs and technical documentation
  • Coordinate with Engineering, C&Q, Construction, Operations, Quality, and vendors
  • Support commissioning and qualification activities throughout the project lifecycle
  • Track project progress, risks, action items, and key milestones
  • Coordinate contractors and vendors supporting assigned project scopes
  • Participate in design reviews, technical meetings, field walkdowns, and construction coordination
  • Support equipment, systems, utilities, and facility-related engineering activities
  • Assist with system turnover, commissioning, startup, and operational readiness
  • Drive resolution of technical and execution-related issues

** Qualifications**

  • 7+ years of engineering, C&Q, commissioning, validation, or capital project experience
  • Strong Commissioning & Qualification (C&Q) background
  • Experience supporting large-scale pharmaceutical or GMP capital projects
  • ** API manufacturing experience strongly preferred**
  • ** Peptide API experience highly desirable**
  • ** Experience with engineering design review and redlining**
  • ** Experience coordinating contractors, vendors, and cross-functional project teams**
  • ** Ability to independently own project scopes and drive them to completion**
  • ** Strong communication, meeting leadership, and organizational skills**
  • ** Comfortable working in an active construction/field environment**
  • ** Must be physically capable of navigating the site, including climbing scaffolding as required**

** Key Skills:** C&Q, project engineering, API/peptide manufacturing, GMP capital projects, engineering design review, construction coordination, commissioning, qualification, contractor management, project scope ownership, and cross-functional leadership.

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