Validation Project Manager
Validation Project Manager
Posted on :
15-11-2024
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1 Vacancy
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Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multicultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
The Validation Project Manager is responsible for leading commissioning qualification and validation projects for pharmaceutical facilities utilities and equipment. Our Validation Project Managers play a critical role in overseeing project planning CQV execution and ensuring the operational readiness of capital projects in order to support our clients success.
- Drive project success by assessing priorities and project plans schedule and budget and ensure timely and effective resolution of potential risks and issues.
- Develop and execute commissioning qualification and validation protocols for required equipment and systems.
- Prepare and maintain comprehensive documentation including validation protocols plans reports and standard operating procedures.
- Identify and assess risks associated with CQV activities and develop mitigation strategies.
- Troubleshoot and resolve issues related to equipment and process performance.
- Collaborative with crossfunctional teams to ensure alignment on CQV activities and project timelines.
- Serve as liaison between vendors and contractors coordinating required handoffs.
- Ensure compliance with regulatory requirements (FDA EMA etc.) and industry standards (GMP GAMP etc.).
- Provide ongoing support and technical expertise through validation execution and qualification activities.
Requirements
- Bachelor s degree in engineering or a related field.
- 10 years of commissioning qualification and validation engineering experience in the pharmaceutical and/or biotech industries.
- Proven success in project management leading CQV projects and experience with project management methods and tools. Experienced coordinating schedules timelines resources and budgets.
- Advanced knowledge of regulatory requirements and industry standards.
- Experience with validation lifecycle management and riskbased approaches.
- Expertise in full CQV project lifecycle execution from planning initiation execution and closeout.
- Excellent analytical and technical problem solving skills. Ability to analyze project risks effectively and implement resolutions.
- Strong technical writing skills and understanding of full lifecycle documentation (protocols reports procedures risk assessments specifications and requirements etc.)
- Effective communication and interpersonal skills. Ability to manage stakeholder communication and crossfunctional team collaboration.
- Proactive with strong organization and time management skills.
- Excellent attention to detail with commitment to quality and compliance.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
This is a W2 Temp position with potential FTE extension. Our W2 Temp employees receive our medical and sick time benefits.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LIRW1
Bachelor s degree in engineering or a related field. 10+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries. Proven success in project management, leading CQV projects, and experience with project management methods and tools. Experienced coordinating schedules, timelines, resources, and budgets. Advanced knowledge of regulatory requirements and industry standards. Experience with validation lifecycle management and risk-based approaches. Expertise in full CQV project lifecycle execution from planning, initiation, execution, and closeout. Excellent analytical and technical problem solving skills. Ability to analyze project risks effectively and implement resolutions. Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills. Ability to manage stakeholder communication and cross-functional team collaboration. Proactive with strong organization and time management skills. Excellent attention to detail with commitment to quality and compliance. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Employment Type
Full Time
Key Skills
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