What are the responsibilities and job description for the Validation Project manager (CSV) position at NexInfo Solutions, Inc.?
Job Details
Hi,
Hope you are doing well.
Job Role: Validation Project manager
Location: La-Verne, CA
About the Role:
We are seeking an experienced Validation Project Manager to lead and oversee validation activities within pharmaceutical manufacturing operations. The ideal candidate will have a strong background in managing validation projects related to manufacturing systems, processes, and equipment, ensuring compliance with GxP, GMP, 21 CFR Part 11, and FDA regulations.
This role requires exceptional project management skills, a deep understanding of validation lifecycle activities, and the ability to collaborate with cross-functional teams to ensure that drug manufacturing processes meet regulatory and quality standards.
Key Responsibilities:
- Lead end-to-end validation projects, including equipment, utilities, facilities, and computerized systems within pharmaceutical manufacturing.
- Develop and execute Validation Master Plans (VMPs), Risk Assessments, IQ/OQ/PQ protocols, and related documentation.
- Ensure compliance with GMP, GxP, 21 CFR Part 11, and FDA regulatory requirements throughout validation activities.
- Manage project timelines, budgets, and resources, ensuring milestones are met.
- Collaborate with cross-functional teams, including Quality Assurance (QA), Engineering, Manufacturing, and IT, to align validation activities with business objectives.
- Oversee computer system validation (CSV) for manufacturing systems, ensuring data integrity and compliance.
- Conduct gap analyses and implement remediation plans for existing validation processes.
- Interface with regulatory agencies and participate in audits and inspections as the validation subject matter expert (SME).
- Identify process improvement opportunities and implement best practices in validation methodologies.
- Manage external vendors and consultants involved in validation activities.
- Provide training and guidance to internal teams on validation processes and regulatory updates.
Required Skills and Qualifications:
- Bachelor s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related field.
- 7 years of experience in validation project management within pharmaceutical manufacturing or related drug industries.
- Strong understanding of GMP, GxP, 21 CFR Part 11, FDA regulations, and industry validation standards.
- Proven experience managing IQ/OQ/PQ validation protocols and Validation Master Plans (VMPs).
- Solid knowledge of computer system validation (CSV) principles.
- Proficiency in project management tools and methodologies (e.g., Agile, Waterfall, MS Project, or JIRA).
- Experience handling regulatory inspections and audits as a validation SME.
- Excellent leadership, organizational, and stakeholder management skills.
- Strong problem-solving abilities and attention to detail.
- Exceptional verbal and written communication skills.
Preferred Skills:
- PMP, PRINCE2, or equivalent project management certification.
- Knowledge of ISO standards applicable to pharmaceutical manufacturing.
- Familiarity with SAP S/4HANA, SCADA, MES, and LIMS integration projects.
- Experience with data integrity principles (ALCOA ).
- Previous experience in sterile manufacturing environments or biotech sectors.
Regards,
Harsha Jakheriya
USA- ( 1)
