Onsite Senior CQV Engineer for Peptide Manufacturing (GMP)

i-Pharm GxP; Indiana; Vor Ort; USD 105.000 - 160.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CQV experience

Peptide processes

GMP knowledge

Protocol development

P&ID walkdowns

Ausbildung

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

Tools

Kneat

DeltaV

DCS (P&ID)

Jobbeschreibung

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.