Validation Project Lead
Validation Project Lead
Posted on :
10-10-2024
Employer Active
1 Vacancy
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Jobs by Experience
5years
Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-10-2024
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 to form something truly special. When you decide 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
- Collaborate with crossfunctional teams to create and maintain project plans scope requirements and timelines ensuring project milestones are met on time and within budget.
- Host project meetings to provide status updates to stakeholders and team members.
- Effectively communicate all project findings risks etc. to stakeholders to ensure appropriate corrective action plans.
- Assess deviations and identify areas of improvement and associated action items.
- Conduct thorough technical evaluations across all required equipment and systems effectively identifying acceptance criteria potential risks and troubleshooting.
- Develop review and redline Piping and Instrumentation Diagrams (P&IDs) ensuring compliance with industry standards and regulations.
- Prepare and maintain detailed project documentation including reports risk assessments validation protocols etc.
- Collaborate with vendors for equipment/system requirements and compliance with project specifications.
- Assist with project closeouts and provide summaries/feedback for proposed process changes.
- Provide ongoing technical guidance support and execution throughout required CQV and related projects.
- Additional responsibilities as required.
Requirements
- Bachelor s Degree in related engineering discipline.
- 510 years of validation project management experience in the pharmaceutical/biotech industry.
- Highly skilled in drafting reviewing and redlining P&IDs.
- AutoCAD experience is a plus.
- Strong understanding of industry regulations and quality standards.
- Strong understanding of validation lifecycle in cGMP environments.
- Proven experience with asset management systems.
- Computer and technical software proficiency.
- Strong analytical and problemsolving abilities.
- Effective communication and interpersonal skills.
- Excellent attention to detail and commitment to quality and compliance.
- Ability to work independently and manage multiple priorities.
- 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
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more).
- Financial Perks and Discounts
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $85000 $125000 annually. The offered salary may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
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.
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Bachelor s Degree in related engineering discipline. 5-10 years of validation project management experience in the pharmaceutical/biotech industry. Highly skilled in drafting, reviewing, and redlining P&IDs. AutoCAD experience is a plus. Strong understanding of industry regulations and quality standards. Strong understanding of validation lifecycle in cGMP environments. Proven experience with asset management systems. Computer and technical software proficiency. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills. Excellent attention to detail and commitment to quality and compliance. Ability to work independently and manage multiple priorities. 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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