What are the responsibilities and job description for the Process Validation Manager position at Harba Solutions Inc.?
Job Responsibilities:
- Lead, develop, and oversee a team of process validation engineers, providing direction on both technical execution and professional growth
- Establish team objectives, conduct performance reviews, and implement development plans to strengthen individual and group capabilities
- Partner with senior leadership and HR to support hiring, onboarding, and long-term workforce planning
- Own resource planning, prioritization, and allocation across multiple validation programs and site initiatives
- Drive a culture of accountability, continuous improvement, and safety within the team
- Serve as a primary technical representative during regulatory inspections, customer audits, and external engagements
- Define and advance validation strategies across the product lifecycle, including process qualification and continued verification
- Evaluate and implement new technologies, manufacturing platforms, and data-driven solutions to improve efficiency and compliance
- Review and approve key validation deliverables such as protocols, reports, risk assessments, and lifecycle documentation
- Act as a senior technical interface for clients and internal stakeholders, supporting complex discussions and business development efforts
- Lead investigations into significant process issues, ensuring thorough root cause analysis and effective CAPA implementation
- Ensure all activities are conducted in accordance with cGMP requirements and internal quality standards
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related field required; advanced degree preferred
- 6 years of experience in a Pharma/CDMO GMP-regulated environment
- 3 years of leadership experience within process validation or technical operations
- Strong background in process validation for pharmaceutical or combination product manufacturing (e.g., formulation, aseptic processing, device assembly)
- Deep understanding of validation lifecycle concepts, regulatory expectations (CMC), and risk management approaches
- Proven ability to lead teams, manage competing priorities, and drive results in a fast-paced environment
- Experience supporting regulatory inspections and interacting with external agencies or clients
- Strong analytical, problem-solving, and communication skills
Salary : $130,000 - $150,000