CSV/CSA Consultant

Tekgence Inc; Frankford (DE); On-site; USD 110,000 - 170,000; Full time

Job summary

Tekgence Inc. is seeking an experienced professional to lead the implementation and integration of GMP Quality Control (QC) Laboratory Systems in a regulated environment.

The role requires coordinating configuration, data migration, deployment, and active stakeholder engagement. You will manage project execution, support CSV/CSA activities, and ensure IQ/OQ/PQ validation documentation and testing, while maintaining compliance with GxP, GAMP5, and Roche standards.

Qualifications

• 8+ years of experience in Pharmaceutical, Biotechnology, or regulated GMP environments.
• Lead implementation and integration of GMP Quality Control (QC) Laboratory Systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement activities.
• Manage project execution including kick-off meetings, project planning, risk management, timelines, quality, and budget tracking.
• Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities.
• Perform and support IQ, OQ, PQ, validation documentation, testing, and compliance activities.
• Ensure compliance with GxP, GAMP5, Data Integrity, and Roche validation standards.
• Collaborate with QA, IT, business stakeholders, laboratory teams, and third-party vendors.
• Support system integrations, release readiness, user acceptance, and production go-live activities.
• Experience with laboratory systems such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar platforms.
• Strong project coordination, Agile/Scrum, stakeholder management, and documentation skills.

Responsibilities

• Lead implementation and integration of GMP QC laboratory systems across biotech/pharma environments.
• Coordinate configuration, data migration, deployment, and stakeholder engagement.
• Manage project execution including kickoff, planning, risk management, timelines, quality, and budgets.
• Support CSV/CSA activities and validation testing with IQ/OQ/PQ documentation.
• Ensure GxP, GAMP5, Data Integrity, and Roche validation standards are met.
• Collaborate with QA, IT, business stakeholders, labs, and vendors.
• Support system integrations, release readiness, user acceptance, and production go-live.

Skills

Laboratory systems leadership

Agile/Scrum

Project coordination

Data migration

Stakeholder management

Validation

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Job description

8+ years of experience in Pharmaceutical, Biotechnology, or regulated GMP environments.

Lead implementation and integration of GMP Quality Control (QC) Laboratory Systems.

Coordinate system configuration, data migration, deployment, and stakeholder engagement activities.

Manage project execution including kick-off meetings, project planning, risk management, timelines, quality, and budget tracking.

Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities.

Perform and support IQ, OQ, PQ, validation documentation, testing, and compliance activities.

Ensure compliance with GxP, GAMP5, Data Integrity, and Roche validation standards.

Collaborate with QA, IT, business stakeholders, laboratory teams, and third-party vendors.

Support system integrations, release readiness, user acceptance, and production go-live activities.

Experience with laboratory systems such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar platforms.

Strong project coordination, Agile/Scrum, stakeholder management, and documentation skills.

Experience with laboratory systems such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar platforms.