LL01-012225 Project Manager for Biotech Operation Readiness
LL01-012225 Project Manager for Biotech Operation Readiness
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1 Vacancy
Job Description
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
- Project Manager Operations Readiness
We are seeking an experienced and dynamic Project Manager for Operations Readiness to join our biotech team. This role ensures the seamless integration of operational processes systems and resources as we transition from project to operational excellence. The Project Manager will lead crossfunctional teams to drive readiness efforts ensuring the organization is equipped to deliver on its strategic objectives while maintaining compliance with regulatory standards.
Key Responsibilities:
1. Operations Readiness Planning:
- Develop and implement a comprehensive operations readiness plan to support facility startup production launches or scaleup projects.
- Coordinate activities between engineering manufacturing quality supply chain and other functional teams to ensure readiness milestones are achieved.
2. Project Management:
- Define project scope objectives deliverables and timelines aligned with organizational goals.
- Manage project budgets resource allocations risks and progress reports.
- Use project management tools and methodologies to monitor project performance and ensure timely .
3. Stakeholder Collaboration:
- Facilitate collaboration among crossfunctional teams vendors and contractors to align efforts and ensure operational goals are met.
- Act as the central point of communication for project updates ensuring all stakeholders are informed and aligned.
4. Risk Management and Compliance:
- Identify potential risks develop mitigation strategies and ensure project plans comply with regulatory standards (e.g. FDA EMA GMP).
- Ensure quality assurance processes are integrated into all operations readiness activities.
5. Change Management:
- Lead organizational change initiatives associated with new processes technologies or systems.
- Develop training plans to prepare teams for operational transitions.
6. Performance Metrics and Continuous Improvement:
- Define and track key performance indicators (KPIs) to measure the success of operational readiness initiatives.
- Identify opportunities for continuous improvement in operational efficiency and scalability.
Qualifications:
- Education: Bachelors degree in engineering life sciences business administration or a related field. Advanced degree (MBA or MS) preferred.
Experience:
- 5 years of project management experience in the biotech pharmaceutical or life sciences industry.
- Proven track record of leading complex crossfunctional projects preferably in operations readiness or facility startup.
Skills:
- Proficiency in project management tools (e.g. MS Project Smartsheet).
- Strong knowledge of GMP FDA EMA and other regulatory requirements.
- Excellent communication leadership and problemsolving skills.
- Ability to manage multiple projects simultaneously in a fastpaced environment.
- Lean Six Sigma or PMP certification is a plus.
Required Experience:
IC
Employment Type
Contract
