Remote Senior C&Q Engineer — GMP Validation Lead

Openkrill

United States

Remote

USD 79,000 - 114,000

Full time

14 days+

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Benefits offered by this job

401(k) Matching

Paid Time Off

Life Insurance

Health Insurance

Dental & Vision

Tuition Reimbursement

Parental Leave

Job summary

Verista seeks a Senior Validation Engineer to lead Commissioning & Qualification programs for GMP facilities and manufacturing systems. You will develop and execute validation protocols, manage risk-based qualification strategies, and ensure documentation quality across global projects.

The role emphasizes cross-functional collaboration with Engineering, Quality, and Operations, with remote work options and limited travel to client sites.

Qualifications

Bachelor's degree in Engineering, Life Sciences or related field.
5+ years in C&Q, commissioning, qualification, or validation in regulated environments.
Hands-on experience with GMP facilities, utilities, equipment, or systems.
Strong knowledge of CMP/verification deliverables and lifecycle management.

Responsibilities

Lead C&Q activities for GMP facilities and manufacturing systems across the project lifecycle.
Develop and execute URS, risk assessments, DQ, IQ/OQ/PQ protocols and reports.
Coordinate field execution, punch-list management, deviations, and closeout.
Maintain Q&Q documentation using electronic systems and ensure compliance.

Skills

C&Q/CQV

GMP

Kneat

Documentation

Cross-functional

Project mgmt

Validation

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

HP ALM/Quality Center

Jira

Documentum

Veeva Vault

Job description

The role emphasizes cross-functional collaboration with Engineering, Quality, and Operations, with remote work options and limited travel to client sites.

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