PSC Biotech
Validation Project Manager
PSC Biotech, New Brunswick, New Jersey, us, 08933
Job DescriptionPSC 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 multi-cultural 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 Project Manager to plan, execute, and manage CQV projects, manage vendors, and provide technical execution review. This role will drive 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 check-outs, other related CQV tasks).Oversee and track the development of user requirements documentation on a system-by-system basis.Collaborate with technical teams, contractors, and equipment vendors to develop system lists and system boundaries.Coordinate instrument and equipment checkout activities.Oversee calibration requirements with instrumentation contractors.Serve as liaison between vendors and contractors, coordinating required hand-offs.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
Bachelor's degree in engineering or related technical field.10+ years of CQV experience in a regulated GMP environment.Experienced with facility build-out requirements and project planning.Experience managing 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.Experience with risk assessment methodologies (e.g., FMEA) and root cause analysis.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.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.
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 employer-sponsored 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.
#LI-RW1
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 multi-cultural 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 Project Manager to plan, execute, and manage CQV projects, manage vendors, and provide technical execution review. This role will drive 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 check-outs, other related CQV tasks).Oversee and track the development of user requirements documentation on a system-by-system basis.Collaborate with technical teams, contractors, and equipment vendors to develop system lists and system boundaries.Coordinate instrument and equipment checkout activities.Oversee calibration requirements with instrumentation contractors.Serve as liaison between vendors and contractors, coordinating required hand-offs.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
Bachelor's degree in engineering or related technical field.10+ years of CQV experience in a regulated GMP environment.Experienced with facility build-out requirements and project planning.Experience managing 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.Experience with risk assessment methodologies (e.g., FMEA) and root cause analysis.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.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.
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 employer-sponsored 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.
#LI-RW1