PSC Biotech
Validation Project Lead
PSC Biotech, Thousand Oaks, California, United States, 91362
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 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 cross-functional 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.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.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 dependentsInsurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.401(k) and 401(k) matchingPTO, Sick Time, and Paid HolidaysEducation AssistancePet InsuranceFitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $125,000 annually. The offered salary may be adjusted based on various factors such as the applicant's 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 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-JL1
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 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 cross-functional 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.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.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 dependentsInsurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.401(k) and 401(k) matchingPTO, Sick Time, and Paid HolidaysEducation AssistancePet InsuranceFitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $125,000 annually. The offered salary may be adjusted based on various factors such as the applicant's 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 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-JL1