Facility Project Engineer (Pharma)

Metric Bio; Denver (CO); On-site; USD 90,000 - 140,000; Full time

Job summary

Metric Bio seeks a Construction & Facility Project Engineer to lead on-site upgrades and new system installations in a fast-growing 503B compounding facility in Colorado. The role demands hands-on management of cleanroom and aseptic environments, with strong knowledge of cGMP regulations including CFR 211 Part 21 and OSHA standards.

Ideal candidates have 3–5 years in aseptic environments, construction experience, and an engineering degree.

Qualifications

• 3–5 years experience within aseptic/cleanroom cGMP environments.
• Must have construction experience.
• cGMP understanding (CFR 211 Part 21) and OSHA/building codes.
• Some project management and CAPEX experience.

Responsibilities

• Own/co-own site shutdowns and contribute to installations of new systems and machinery.
• Oversee the ongoing expansion and upgrade of facilities on-site.
• Collaborate with cross-functional teams to ensure compliance and safe operation.
• Maintain knowledge of boilers and air handlers and other critical plant equipment.

Skills

Cleanroom/Aseptic environments

cGMP facilities

Construction experience

Project management

CAPEX experience

Boilers & air handlers

Education

Engineering degree (Mechanical, Electrical)

Job description

Metric Bio have been retained by an Industry leading 503B Compounding company based in Colorado to assist with the search for a Construction & Facility Project Engineer role based on-site.

Our client are currently in a hyper-growth period, expanding the business across the board - there's no better time to join them.

Widely renowned as the highest quality provider of 503B Compounded, Sterile services in the industry, they primarily focus on Pre-Filled injectables, Ophthalmic Solutions, IV Bags and any other value added Pharmacy product distributing to Hospitals and Pharmacy channels. They have a stellar compliance record with the DEA & FDA being one of 55 FDA Registered 503B facilities in the US.

Metric Bio are looking for an individual withexperience managing and maintaining both Cleanroom/Aseptic environments alongside cGMP Facilities. The successful individual will have priorknowledge of both Construction & Aseptic Pharmaceutical regulations such as OSHA, DEA, FDA.

Being responsible for the site, you must have an understanding of general site maintenance and how Pharmaceutical Operations run - Proficient handling of Boilers & Air handlers for example.

3-5 years experience within Aseptic Environments is required alongside a preference towards an engineering degree of some form (Mechanical, Electrical Engineering etc). Some Project management and CAPEX Experience is also preferred due to the nature of the role with Cleanroom pressurisation understanding a bonus.

You will own/co-own site shutdown whilst contributing to the constant instalments of new systems and machinery to continuously improve the site. The Ability to influence is crucial, you will not have direct reports but you must be able to work well and collaborate well with the team.

To summarise, we are looking for an individual that holds:

• 3-5 years experience within Aseptic/Cleanroom cGMP environments
• Must have Construction experience
• cGMP understanding (CFR 211 Part 21) and national building code (OSHA)
• Some project management and CAPEX Experience