C&Q Technical Lead

BMA Group Global; Carolina (PR); On-site; USD 140,000 - 180,000; Full time

Job summary

BMA Group Global is seeking an experienced Automation / CSV Technical Lead to oversee validation activities for a major pharmaceutical capital project. You will provide technical leadership for automation systems, design and validation planning, and commissioning through handover, ensuring compliance with regulatory requirements.

The ideal candidate has strong expertise in CSV principles, GAMP 5, ALCOA+ data integrity, and IQ/OQ/PQ execution, with proven ability to lead cross-functional teams in

Qualifications

• Bachelor's degree in engineering or related technical field.
• Significant experience leading automation and CSV activities in regulated manufacturing.
• Strong knowledge of CSV principles and lifecycle methodologies.

Responsibilities

• Lead strategy, planning, and execution of CSV activities for automation and computerized systems in manufacturing.
• Provide technical leadership for automation systems across design, commissioning, qualification, and startup phases.
• Develop, review, and approve validation documents (plans, TRACE matrices, protocols, reports).
• Define validation approaches aligned with project and regulatory requirements.
• Collaborate with engineering, quality, operations, and commissioning teams to meet deliverables.
• Support FAT, SAT, commissioning, qualification, and system turnover activities.
• Lead IQ, OQ, PQ execution for automation and computerized systems.
• Manage validation investigations, deviations, discrepancies, and change controls.
• Provide guidance on data integrity and validation best practices.
• Support project scheduling and milestone tracking.
• Develop training materials and knowledge transfer on validated systems.
• Coordinate with vendors and cross-functional stakeholders.

Skills

CSV leadership

Regulatory compliance

Project governance

Cross-functional leadership

Education

Bachelor's degree in engineering or related technical field

Tools

GAMP 5 guidance

IQ/OQ/PQ execution

MES systems

ALCOA+ data integrity

Job description

We are seeking an experienced Automation / Computer System Validation (CSV) C&Q Technical Lead to support a large-scale pharmaceutical manufacturing capital project. This individual will provide technical leadership for automation systems and computerized system validation activities throughout the project lifecycle, from design and validation planning through commissioning, qualification, testing, and operational handover.

The successful candidate will serve as a subject matter expert in automation and computer system validation, ensuring compliance with regulatory requirements, industry best practices, and project objectives within a highly regulated manufacturing environment.

Key Responsibilities

• Lead the strategy, planning, and execution of Computer System Validation (CSV) activities for automation and computerized systems supporting manufacturing operations.
• Provide technical leadership for automation systems throughout design, commissioning, qualification, and startup phases.
• Develop, review, and approve validation documentation, including validation plans, requirements traceability matrices, test scripts, protocols, and summary reports.
• Define validation approaches and ensure alignment with project and regulatory requirements.
• Collaborate with engineering, quality, operations, and commissioning teams to support project deliverables and timelines.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and system turnover activities.
• Lead execution of IQ, OQ, and PQ protocols for automation and computerized systems.
• Manage validation-related investigations, deviations, discrepancies, and change controls.
• Provide guidance regarding data integrity, computerized systems compliance, and validation best practices.
• Contribute to project scheduling, progress reporting, and validation milestone tracking.
• Develop training materials and support knowledge transfer activities related to validated systems.
• Coordinate with vendors, contractors, and cross-functional stakeholders to ensure successful project execution.

Required Qualifications

• Bachelor's degree in Automation Engineering, Electrical Engineering, Chemical Engineering, Computer Science, or a related technical discipline.
• Significant experience leading automation and CSV activities within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Strong knowledge of Computer System Validation (CSV) principles and lifecycle methodologies.
• Experience applying GAMP 5 guidance and data integrity requirements, including ALCOA+ principles.
• Hands-on experience developing and executing validation deliverables, including validation plans, traceability matrices, testing protocols, and final reports.
• Experience with commissioning and qualification activities, including IQ/OQ/PQ execution.
• Knowledge of industrial automation systems, control systems, and regulated manufacturing technologies.
• Ability to manage multiple stakeholders and provide technical leadership across multidisciplinary teams.
• Excellent communication, organization, and problem-solving skills.

Preferred Qualifications

• Previous experience leading CSV, automation, or C&Q activities on large-scale capital projects.
• Familiarity with Manufacturing Execution Systems (MES), data historians, and process automation platforms.
• Experience supporting regulatory inspections, audits, and compliance initiatives.
• Knowledge of alarm management, system lifecycle management, and validation risk assessments.
• Experience working in fast-paced project environments involving multiple contractors and vendors.
• Full-time position.
• Onsite project-based role.
• Opportunity to support a major pharmaceutical manufacturing expansion project.
• Collaborative, multidisciplinary team environment focused on innovation, quality, and compliance.