Valspec · 12 hours ago
Validation Project Manager (Consultant)
Raleigh, NC
Contract
Onsite
Senior Level
5+ years expValspec is a global provider of system validation and lifecycle services in the Life Sciences industry. They are seeking a Validation Project Manager (Consultant) to provide computer system validation support, manage project plans, and ensure compliance in a biopharmaceutical facility.
Software
No H1B
Responsibilities
Manage project plans and delivery for risk management in a large-scale Biopharmaceutical facility
Develop communication plans for risk management related to operations readiness
Conduct weekly meetings and deep dive sessions to monitor milestone objectives
Lead response and action plans for issues affecting on-time, high-quality operations readiness
Qualification
Required
Bachelor's degree in engineering, Computer Science, or a related field
Minimum of 5 years of experience in CSV and validation within the pharmaceutical or biopharmaceutical industry
Strong expertise in validating project management in biopharmaceutical environments
In-depth knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP, 21 CFR Part 11) related to CSV and validation
Excellent problem-solving skills and the ability to analyze complex systems and processes
Ability to collaborate effectively with cross-functional teams
Proactive mindset with a strong attention to detail and the ability to prioritize tasks effectively
Experience working in a regulated GxP environment
Benefits
Premium medical coverage
401(k) with company match
Tuition reimbursement
Unique performance incentives
And more — all designed to support your growth, well-being, and future.
Company
Valspec
VALSPEC is the leading provider of computer system validation and system life cycle services including testing, commissioning, etc.
51-200 employees
Funding
Current Stage
Growth StageRecent News
2023-10-11
2022-11-11
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