PSC Biotech
Validation Project Manager
PSC Biotech, Indianapolis, Indiana, us, 46262
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 Validation Project Manager. Successful candidates will have a strong technical background in equipment/system commissioning, qualification, and validation coupled with excellent communication, organization, and project management capabilities.
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, regulations, etc.Develop, review, and execute commissioning, qualification, and validation protocols for required equipment, facilities, utilities, and systems.Conduct risk assessments and develop mitigation strategies for validation projects. Identify, document, and manage deficiencies and deviations.Ensure corrective and preventive action and change control requirements are efficiently met.Maintain accurate and detailed documentation of all validation activities, including protocols, reports, master plans, engineering specifications (URS, DS, FS, etc.), etc.Serve as liaison between vendors and contractors, coordinating required hand-offs.Identify opportunities for process improvements and implement best practices in validation activities.Provide ongoing support and technical expertise through validation execution and qualification activities.Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.Additional responsibilities as required.Requirements
Bachelor's degree in related engineering discipline.7+ years of commissioning, qualification, and validation engineering experience with a wide range of equipment and systems experience in the pharmaceutical manufacturing industry.Proven success in managing, reviewing, authoring, and approving full lifecycle technical validation documentation.Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.Experienced in vendor coordination/management.Advanced knowledge of industry regulations and standards. Strong knowledge of risk-based validation approach.Experienced in paperless validation (Kneat, ValGenesis, etc.) is a plus.Strong understanding of industry regulations and requirements.Strong attention to detail and commitment to quality and compliance.Excellent problem solving and analytical skills.Excellent communication and interpersonal 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
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
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 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 Validation Project Manager. Successful candidates will have a strong technical background in equipment/system commissioning, qualification, and validation coupled with excellent communication, organization, and project management capabilities.
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, regulations, etc.Develop, review, and execute commissioning, qualification, and validation protocols for required equipment, facilities, utilities, and systems.Conduct risk assessments and develop mitigation strategies for validation projects. Identify, document, and manage deficiencies and deviations.Ensure corrective and preventive action and change control requirements are efficiently met.Maintain accurate and detailed documentation of all validation activities, including protocols, reports, master plans, engineering specifications (URS, DS, FS, etc.), etc.Serve as liaison between vendors and contractors, coordinating required hand-offs.Identify opportunities for process improvements and implement best practices in validation activities.Provide ongoing support and technical expertise through validation execution and qualification activities.Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.Additional responsibilities as required.Requirements
Bachelor's degree in related engineering discipline.7+ years of commissioning, qualification, and validation engineering experience with a wide range of equipment and systems experience in the pharmaceutical manufacturing industry.Proven success in managing, reviewing, authoring, and approving full lifecycle technical validation documentation.Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.Experienced in vendor coordination/management.Advanced knowledge of industry regulations and standards. Strong knowledge of risk-based validation approach.Experienced in paperless validation (Kneat, ValGenesis, etc.) is a plus.Strong understanding of industry regulations and requirements.Strong attention to detail and commitment to quality and compliance.Excellent problem solving and analytical skills.Excellent communication and interpersonal 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
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
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 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