What are the responsibilities and job description for the C&Q Area Lead Project Manager & Scheduler | Onsite position at Stellent IT LLC?
Job Details
Hi,
We have urgent role of C&Q Area Lead Project Manager & Scheduler | Onsite. Please revert if you are interested in applying.
C&Q Area Lead Project Manager & Scheduler
Location: Harrisburg, PA (Onsite)
Type: Contract
Job Description :-
We are seeking a highly organized and proactive Project Manager & Scheduler to lead the planning, coordination, and execution of Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical and life science projects. This role is critical in ensuring that CQV activities are effectively integrated into the overall project plan, optimizing timelines, resources, and compliance with industry regulations.
Key Responsibilities:
Project Planning & Scheduling: Develop, maintain, and optimize project schedules for CQV activities using Primavera P6, MS Project, or equivalent tools.
Project Coordination: Work closely with Project Managers, CQV Engineers, and cross-functional teams to align CQV timelines with construction, installation, and operational readiness milestones.
Risk & Critical Path Management: Identify critical path activities, potential bottlenecks, and schedule risks, proposing mitigation strategies to ensure on-time project delivery.
Progress Monitoring & Reporting: Track and report CQV progress, providing status updates, KPIs, dashboards, and risk assessments to stakeholders and senior management.
Resource Allocation & Optimization: Support resource planning by ensuring efficient allocation of personnel, equipment, and documentation workflows.
Change & Stakeholder Management: Assess the impact of schedule changes and work collaboratively with project stakeholders to implement adjustments while maintaining project objectives.
Regulatory & Compliance Adherence: Ensure all CQV scheduling activities comply with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory requirements (FDA, EMA, etc.).
Qualifications & Experience:
Bachelor's degree in Engineering, Project Management, or a related field (or equivalent experience)
Minimum 8 years of experience in project scheduling and management for CQV, commissioning, or validation projects in the pharmaceutical, biotech, or life sciences industry
Strong proficiency in Primavera P6, MS Project, or other project scheduling tools.
In-depth understanding of CQV processes, project execution methodologies, and regulatory compliance (GMP, FDA, EMA, etc.).
Demonstrated ability to coordinate multidisciplinary teams and manage complex projects with multiple stakeholders.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and reporting abilities, capable of presenting project updates to both technical and non-technical audiences.
Ability to work in a fast-paced environment, managing multiple priorities and adapting to evolving project needs.
Preferred Qualifications:
PMP, PRINCE2, or equivalent project management certification.
Experience managing large-scale biotech or pharmaceutical facility projects.
Knowledge of risk management, delay analysis techniques, and project controls best practices.
Job Description :-
We are seeking a highly organized and proactive Project Manager & Scheduler to lead the planning, coordination, and execution of Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical and life science projects. This role is critical in ensuring that CQV activities are effectively integrated into the overall project plan, optimizing timelines, resources, and compliance with industry regulations.
Key Responsibilities:
Project Planning & Scheduling: Develop, maintain, and optimize project schedules for CQV activities using Primavera P6, MS Project, or equivalent tools.
Project Coordination: Work closely with Project Managers, CQV Engineers, and cross-functional teams to align CQV timelines with construction, installation, and operational readiness milestones.
Risk & Critical Path Management: Identify critical path activities, potential bottlenecks, and schedule risks, proposing mitigation strategies to ensure on-time project delivery.
Progress Monitoring & Reporting: Track and report CQV progress, providing status updates, KPIs, dashboards, and risk assessments to stakeholders and senior management.
Resource Allocation & Optimization: Support resource planning by ensuring efficient allocation of personnel, equipment, and documentation workflows.
Change & Stakeholder Management: Assess the impact of schedule changes and work collaboratively with project stakeholders to implement adjustments while maintaining project objectives.
Regulatory & Compliance Adherence: Ensure all CQV scheduling activities comply with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory requirements (FDA, EMA, etc.).
Qualifications & Experience:
Bachelor's degree in Engineering, Project Management, or a related field (or equivalent experience)
Minimum 8 years of experience in project scheduling and management for CQV, commissioning, or validation projects in the pharmaceutical, biotech, or life sciences industry
Strong proficiency in Primavera P6, MS Project, or other project scheduling tools.
In-depth understanding of CQV processes, project execution methodologies, and regulatory compliance (GMP, FDA, EMA, etc.).
Demonstrated ability to coordinate multidisciplinary teams and manage complex projects with multiple stakeholders.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and reporting abilities, capable of presenting project updates to both technical and non-technical audiences.
Ability to work in a fast-paced environment, managing multiple priorities and adapting to evolving project needs.
Preferred Qualifications:
PMP, PRINCE2, or equivalent project management certification.
Experience managing large-scale biotech or pharmaceutical facility projects.
Knowledge of risk management, delay analysis techniques, and project controls best practices.
Avnish Rao
Technical Recruiter
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