Job ID: JOB_ID_316
Position Summary
We are looking for a seasoned Technical Project Manager specializing in Pharma Validation for a critical 12-month onsite engagement in Rensselaer, NY. This role is pivotal for overseeing capital-scale projects within a GxP-regulated environment. The successful candidate will bridge the gap between technical engineering teams and regulatory compliance requirements, ensuring that all systems meet stringent validation standards. This position requires a deep understanding of pharmaceutical manufacturing processes and the technical systems that support them.
Key Responsibilities
- Manage the end-to-end lifecycle of pharmaceutical validation projects, focusing on CSV (Computer System Validation) and CSA (Computer Software Assurance) methodologies.
- Coordinate project planning and scheduling on a capital scale, ensuring milestones are met within budget and scope.
- Lead cross-functional teams to implement and validate Rockwell and Factory Talk Batch systems from a project management perspective.
- Ensure all project activities comply with GxP environments and pharmaceutical industry regulations, maintaining audit-ready documentation.
- Utilize Project 2021 and Jira for meticulous tracking of project progress, resource allocation, and task management.
- Communicate effectively with stakeholders at all levels, providing clear updates on project status, risk mitigation strategies, and resource needs.
- Facilitate technical discussions between engineering, quality assurance, and production departments to ensure seamless integration of new systems.
Technical Qualifications
- Minimum of 5 years of experience in Technical Project Management specifically within the pharmaceutical or life sciences sector.
- In-depth technical understanding of Rockwell Automation and Factory Talk Batch systems.
- Proven expertise in CSV/CSA validation expertise and hands-on experience with validation protocols.
- Extensive experience in project planning and scheduling for large-scale capital improvements.
- Experience with Plant PAX is highly desirable and considered a significant plus.
- Excellent communication skills and a proven ability to work cross-functionally in a complex corporate environment.
Work Environment and Constraints
- This is a strictly onsite position located in Rensselaer, New York; candidates must be local or willing to relocate for the duration of the contract.
- Candidates must be able to work without H1B sponsorship (No H1B).
- The initial duration is 12 months with a high probability of extensions based on performance and project needs.
- The role requires a high degree of collaboration with engineering, quality assurance, and production departments to ensure compliance with safety and regulatory standards.
Special Requirements
No H1B, Onsite Rensselaer, NY, 12mo w/ extensions
Compensation & Location
Salary: $150,000 – $200,000 per year (Estimated)
Location: Rensselaer, NY
Recruiter / Company – Contact Information
Recruiter / Employer: Stellent IT
Email: aditya@stellentit.com
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