Project Consultant - Pharma Manufacturing

NIRAS

З HR-Manager

Would you like to work on pharmaceutical manufacturing projects and help bring structure and momentum to complex programmes?

Join our Pharma & Life Science team in the US

NIRAS is a foundation- and employee-owned engineering consultancy founded in Denmark in 1956. Around 3,000 colleagues work from more than 60 offices on some 9,000 projects, under one purpose: engineering solutions for a shared future. Our values are simple: we listen, we learn, we deliver.

NIRAS Inc. is NIRAS' North American business, based in Cary, North Carolina. We are a team of about 20 consultants supporting global pharma, biotech and food & beverage manufacturers across capital programmes, PMO, CQV and FDA remediation. Our consultants currently work with clients across North Carolina, Indiana, New Jersey and Pennsylvania. With more than USD 370bn of new US pharma investment announced, we plan to roughly double in size by 2030, so the people who join now will help shape the business.

Your role

Our client, a global pharmaceutical manufacturer, is integrating and expanding a large sterile fill-finish site in Bloomington, IN. The site is running a major capital and integration program alongside remediation of FDA inspection findings, and needs people who can bring structure, follow-up and momentum.

As a NIRAS Project Consultant you join our on-site team and work inside the client's project organization: supporting project managers on new vial and fill lines, and driving the governance that gets open deviations, CAPAs and audit actions closed on time. Early-career candidates will learn fast alongside senior NIRAS program leaders; experienced candidates can take ownership of a workstream from day one.

What you will do

Support project managers on capital projects and line expansions: schedules, action logs, risk registers, meeting cadence and status reporting

  • Drive follow-up on open deviations, CAPAs and FDA commitments with the site's business owners and SMEs, and keep priorities and due dates visible
  • Build and maintain trackers, dashboards and management reports that turn scattered data into clear decisions
  • Prepare and facilitate project and governance meetings; capture decisions and ensure actions are followed through
  • Coordinate across engineering, quality, validation, manufacturing and vendors
  • Use AI tools and simple automation to speed up tracking, data analysis, meeting minutes and reporting
  • Spot gaps and improvement opportunities on site and raise them with the NIRAS team

What you bring

Must have

  • B.Sc. or M.Sc. in engineering, life sciences or a related field
  • 1–8 years of experience in pharma, biotech, medical devices or another regulated manufacturing environment (internships and co-ops count)
  • A structured approach and the ability to keep track of multiple activities and follow them through
  • Good working knowledge of Excel and MS Project, Smartsheet or similar tools
  • Practical, everyday use of AI tools (e.g. Microsoft Copilot, ChatGPT or Claude) to analyze data, draft reports and speed up follow-up, and the judgment to check AI output in a GMP environment
  • Clear written and spoken English and the confidence to follow up with senior stakeholders
  • Authorized to work in the US and able to work on site in Bloomington

Nice to have

  • Experience with GMP, deviations and CAPA, or FDA inspection follow-up
  • Knowledge of aseptic / sterile fill-finish operations
  • Experience with capital projects, CQV or technology transfer
  • Power BI or other data and reporting tools

What we offer

  • A small, flat US team where your voice counts, backed by the engineering depth of 3,000 NIRAS colleagues worldwide
  • Leadership roles on client sites from day one, and a clear path toward Senior Consultant and Regional Account Manager (on-site client lead) roles
  • Exposure to some of the largest pharma manufacturing investments in the US
  • Coaching from senior program leaders with decades of GMP, capital project and FDA experience
  • Competitive salary and benefits package

How to apply

If the role sounds interesting to you, we would be happy to hear from you. Please apply directly through this page. We review applications on an ongoing basis and encourage you to apply as soon as possible.

Location: Bloomington, IN (on site, typically 4–5 days a week)

Start date: November 2026.

 

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