Senior Process Engineer

i-Pharm GxP; Lebanon (IN); On-site; USD 96,000 - 152,000; Full time

Job summary

i-Pharm GxP in Lebanon, Indiana, seeks an experienced Senior C&Q Process Equipment Engineer to lead commissioning and qualification of API manufacturing equipment from construction through handover.

The role is a 12-month contract, fully onsite in Lebanon, Indiana, with an competitive W2 hourly rate and involvement across reactors, dryers, chromatography skids, lyophilizers and solvent recovery systems.

Qualifications

• 5+ years of hands-on C&Q in pharmaceutical or biotech GMP facilities.
• Process equipment experience in small-molecule API, peptide or biologics manufacturing.
• Protocol writing and execution experience in Kneat.
• Peptide experience and greenfield project experience are a strong plus.

Responsibilities

• Commissioning and qualifying API process equipment, including reactors, filter dryers, chromatography skids, lyophilizers and solvent recovery systems
• Carrying out P&ID walkdowns, component verification and functional testing
• Writing and executing IQ/OQ/PQ protocols and supporting FAT/SAT
• Working through punch lists, deviations and turnover packages with Engineering, Automation and QA

Skills

C&Q experience

GMP compliance

Protocol writing

Tools

Kneat

Job description

Senior C&Q Process Equipment Engineer, API | Lebanon, Indiana

We’re looking for an experienced C&Q Process Equipment Engineer to join a major pharmaceutical capital program in Lebanon, Indiana. You’ll sit within the process team, delivering commissioning and qualification of API manufacturing equipment from construction through to handover.

• 12-month contract, with extensions anticipated
• Fully onsite in Lebanon, Indiana
• Competitive W2 hourly rate

What you’ll be doing:

• Commissioning and qualifying API process equipment, including reactors, filter dryers, chromatography skids, lyophilizers and solvent recovery systems
• Carrying out P&ID walkdowns, component verification and functional testing
• Writing and executing IQ/OQ/PQ protocols and supporting FAT/SAT
• Working through punch lists, deviations and turnover packages with Engineering, Automation and QA

What we’re looking for:

• 5+ years of hands-on C&Q in pharmaceutical or biotech GMP facilities
• Process equipment experience in small-molecule API, peptide or biologics manufacturing
• Protocol writing and execution experience in Kneat
• Peptide experience and greenfield project experience are a strong plus