Lead Automation & CSV C&Q for Pharma Expansion

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

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