Senior CQV Engineer

i-Pharm GxP; Indiana; On-site; USD 105,000 - 160,000; Full time

Job summary

i-Pharm GxP in Lebanon, Indiana is seeking a Senior CQV Engineer to join a major peptide API manufacturing capital program. The role is hands-on, field-based, and requires strong experience delivering commissioning, qualification and validation from construction through handover.

Responsibilities include IQ/OQ/PQ protocol development, P&ID walkdowns, and collaboration with cross-functional teams to ensure GMP-compliant systems. 12-month contract with full onsite work five days a week.

Qualifications

• 5+ years of hands-on C&Q experience in pharmaceutical or biotech GMP facilities.
• Direct experience with peptide or synthetic API manufacturing equipment.
• Experience developing and executing IQ/OQ/PQ protocols, preferably in Kneat or a similar electronic validation system.

Responsibilities

• Commissioning and qualifying peptide manufacturing equipment in the field.
• Support utilities and containment systems installation and qualification.
• Perform P&ID walkdowns, loop checks and functional testing in the field.
• Develop and execute IQ/OQ/PQ protocols and support FAT/SAT activities.
• Resolve punch lists, deviations and troubleshooting to keep systems moving.
• Build turnover packages and traceability matrices for handover.
• Collaborate with Construction, Engineering, Automation, Validation and QA to meet GMP standards.

Skills

CQV experience

Peptide processes

GMP knowledge

Protocol development

P&ID walkdowns

Education

Bachelor's degree in Engineering, Chemistry, Life Sciences or related field

Tools

Kneat

DeltaV

DCS (P&ID)

Job description

Senior CQV Engineer, Peptide Manufacturing | Lebanon, Indiana

We're looking for an experienced Senior CQV Engineer to join a major pharmaceutical capital program in Lebanon, Indiana. You'll sit within the process team, delivering commissioning, qualification and validation of peptide API manufacturing equipment from construction through to handover.

This is a hands-on, field-based role for someone who knows peptide processes, is comfortable working alongside construction and engineering, and can contribute from day one.

• Initial 12-month contract, with extensions anticipated
• Fully onsite in Lebanon, Indiana, five days a week

What you'll be doing:

• Commissioning and qualifying peptide manufacturing equipment, including solid-phase peptide synthesis (SPPS) reactors, cleavage and precipitation systems, preparative HPLC and chromatography skids, lyophilizers and solvent handling and recovery systems.
• Supporting the supporting utilities, including nitrogen, process chillers, purified water, CIP and containment systems.
• Carrying out P&ID walkdowns, loop checks, component verification and functional testing in the field.
• Developing and executing IQ/OQ/PQ protocols, ideally in Kneat, and supporting FAT/SAT.
• Working through punch lists, deviations and troubleshooting to keep systems moving.
• Building turnover packages and traceability matrices for handover.
• Working with Construction, Engineering, Automation, Validation and QA to deliver systems to GMP standards.

What we're looking for:

• 5+ years of hands-on C&Q experience in pharmaceutical or biotech GMP facilities.
• Direct experience with peptide or synthetic API manufacturing equipment.
• Protocol development and execution experience, ideally in Kneat or a similar electronic validation system.
• A good understanding of cGMP, ASTM E2500 and risk-based C&Q.
• Experience with solvent-handling or explosion-proof (ATEX/Class I Div 1) environments is a strong plus.
• Greenfield or facility expansion experience is a strong plus. Exposure to DeltaV or other DCS platforms­-??
• A Bachelor's degree in Engineering, Chemistry, Life Sciences or a related technical field.
• Availability for overtime and occasional weekend work when the schedule requires it.