Validation Project E....
Validation Project Engineer
Posted on :
16-04-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2722402
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
We are hiring an experienced Validation Project Engineer. This role will drive successful project execution and completion handling document management testing activities as well as managing schedules test materials and vendor coordination. Successful candidates will have a strong technical background in equipment/system commissioning qualification and validation coupled with excellent communication organization and project coordinating capabilities.
- Generate revise and manage validation lifecycle documentation including user requirements functional and design specifications configuration specifications computerized systems assessments asset inductions and validation protocols and required reports.
- Generate and manage project plans preventative maintenance coordination and risk mitigation.
- Drive project success through efficient project coordination. This includes managing schedules test materials and handling vendor coordination.
- Coordinate with crossfunctional teams to align on project schedules plans and deliverables.
- Support overall engineering testing activities by developing revising and executing commissioning validation and SAT protocols.
- Provide ongoing support and technical expertise through validation execution and qualification activities.
- Conduct risk analyses and identify potential risks recommending areas of improvement.
- Support SOP review and approval.
- Attend required trainings as needed.
- Ensure compliance with industry regulations and requirements always.
- Additional responsibilities as required.
Requirements
- Bachelors degree in related engineering discipline.
- 5 years of commissioning qualification and validation engineering experience in the pharmaceutical/life science industry.
- Proven success in managing reviewing authoring and approving full lifecycle technical documentation.
- Strong understanding of engineering specifications and requirements.
- Experienced generating and executing CQV activities on a range of equipment and systems.
- Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members and schedule/develop project plans.
- Experienced in vendor coordination.
- Excellent technical writing skills.
- Strong understanding of industry regulations and requirements.
- Excellent communication and interpersonal skills.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- 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
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Estimated Annual Salary (dependent on experience) $90000 $110000.
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+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical/life science industry. Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation. Strong understanding of engineering specifications and requirements. Experienced generating and executing CQV activities on a range of equipment and systems. Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans. Experienced in vendor coordination. Excellent technical writing skills. Strong understanding of industry regulations and requirements. Excellent communication and interpersonal skills. Strong attention to detail and commitment to quality and compliance. Strong problem solving and analytical skills. 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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