Senior CIP/CQV Engineer - GMP Biotech Systems

Verista; Apex (NC); Presencial; USD 108 000 - 168 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health Insurance

401(k) Matching

Paid Time Off

Tuition Reimbursement

Dental & Vision

Resumo da oferta

Verista is seeking a Clean-in-Place (CIP) Engineer on site in Apex, NC, to lead commissioning and qualification for CIP systems within GMP environments. You will develop C&Q documentation, coordinate with design engineers, and ensure systems meet quality and safety standards.

Responsibilities include leading CIP cycles, URS/QRAES development, IOQ protocols, and collaboration with automation and SME teams to finalize test plans; you will support FATs/SATs and maintain system ownership

Qualificações

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related discipline.
• 10+ years of role-specific experience.
• Experience supporting CQV activities in GMP-regulated pharma/biotech environments.
• Hands-on experience with CIP systems and automated cleaning processes.
• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ).
• Ability to work independently while coordinating with cross-functional project teams.
• Strong technical documentation and communication skills.
• Experience using Kneat validation platform.
• Experience supporting FAT/SAT, commissioning, and equipment startup.
• Familiarity with automated process systems and PLC-based equipment.
• Experience in biologics or large-scale biopharmaceutical manufacturing environments.
• Onsite job requirement in Apex, NC.

Responsabilidades

• Serve as the commissioning and qualification (C&Q) lead for CIP systems; develop and optimize CIP cleaning cycles.
• Develop URS and Quality Risk Assessments for Equipment and Automated Systems.
• Prepare and submit summary reports documenting commissioning and qualification activities.
• Coordinate with Automation Team for automation functional testing and IOQ protocols.
• Attend daily commissioning meetings and oversee FATs/SATs as required.
• Take custody of systems post-construction and maintain ownership through C&Q completion.

Conhecimentos

CQV lifecycle

Technical documentation

Cross-functional teamwork

Independent work

Startup experience

Formação académica

Bachelor’s degree in Engineering/Life Sciences

Ferramentas

Kneat

Descrição da oferta de emprego

Verista is seeking a Clean-in-Place (CIP) Engineer on site in Apex, NC, to lead commissioning and qualification for CIP systems within GMP environments. You will develop C&Q documentation, coordinate with design engineers, and ensure systems meet quality and safety standards.

Responsibilities include leading CIP cycles, URS/QRAES development, IOQ protocols, and collaboration with automation and SME teams to finalize test plans; you will support FATs/SATs and maintain system ownership