Location
New Brunswick, NJ | United States
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
We are hiring an experienced and motivated Validation Engineer to assist the development of commissioning qualification and validation project planning for a facility build out. The Validation Engineer will be responsible for contracting project management/coordination and driving successful project and deliverable completion adhering to industry standards and regulations.
- Drive project success by assessing priorities and project plans schedule and budget and ensure timely and effective resolution of potential risks and issues.
- Assist in the development of CQV project planning in accordance to project design documentation equipment specifications etc.
- Identify and develop the scope of work required per systems (including loop checks hardware checkouts other related CQV tasks).
- Oversee and track the development of user requirements documentation on a systembysystem basis.
- Collaborate with CQV Team instrumentation contractors and process equipment vendors to develop list of systems and system boundaries. Coordinate instrument and equipment checkout activities.
- Oversee calibration requirements with instrumentation contractors.
- Charged with the handoff of systems between vendors and contractors.
- Manage and review vendor contracts (review timesheets earned value project scope changes etc.)
- Support the development of proposal writing for contracting and CQV resources.
- Ensure effective and active communication with stakeholders project managers on all project updates progress risks resolutions budget contractor and vendor statuses change requests and so on.
- Elevate any potential risks or issues to upper management and determine any potential delays in deliverables.
- Ensure all required documentation is recorded in a timely and efficient manner and meets regulatory and quality guidelines.
- Lead meetings with project managers and team members as needed.
Requirements
- Bachelors degree in engineering or related technical field.
- 5 years of CQV experience in a regulated GMP environment.
- Experienced with facility buildout requirements and project planning.
- Experience working with equipment and instrumentation contractors and vendors.
- Experience supporting proposal writing.
- Strong understanding of regulatory requirements (FDA EMA ICH etc.) and industry standards (GMP GLP GAMP etc.) related to CQV.
- Excellent project management skills including the ability to develop and manage project plans schedules and budgets.
- Exceptional attention to detail and the ability to review technical documentation thoroughly.
- Effective communication and interpersonal skills enabling collaboration with diverse crossfunctional teams.
- Experience with risk assessment methodologies (e.g. FMEA) and root cause analysis.
- Travel is required. 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
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 engineering or related technical field. 5+ years of CQV experience in a regulated GMP environment. Experienced with facility build-out requirements and project planning. Experience working with equipment and instrumentation contractors and vendors. Experience supporting proposal writing. Strong understanding of regulatory requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV. Excellent project management skills, including the ability to develop and manage project plans, schedules, and budgets. Exceptional attention to detail and the ability to review technical documentation thoroughly. Effective communication and interpersonal skills, enabling collaboration with diverse cross-functional teams. Experience with risk assessment methodologies (e.g., FMEA) and root cause analysis. Travel is required. 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.
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