PSC Biotech
Validation Engineer
PSC Biotech, Thousand Oaks, California, United States, 91362
Thousand Oaks, United States
| Posted on 12/12/2023PSC 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 RoleWe are hiring an experienced and motivated Validation Engineer to support commissioning and qualification activities.Generate and execute CQPs, PQs, test plans, reports, and identify any potential associated issues or discrepancies for a variety of equipment and systems.Support all qualification execution and documentation reporting for fill lines, freezers, water baths, CIP/SIP stations for tanks and filter units, vial washers, tunnel sterilizers, and other related/required equipment and systems.Execute required Cx/IQ/OQ test plans.Generate required documentation including but not limited to system assessments, URS, specifications, and so on.Support test case execution and corrective actions.Work collaboratively with cross functional teams to drive project success and completion.Effectively communicate action items, risks, etc. to stakeholders.Additional responsibilities as required.Requirements
Bachelor's degree in related engineering discipline.5+ years of commissioning, qualification, and validation experience in the pharmaceutical industry.Experience in KNEAT validation is preferred.Experienced with fill line equipment.Strong knowledge of aseptic processing and sterilization validation.Strong knowledge of industry regulations and standards.Excellent technical writing skills.Detail oriented and strong commitment to quality.Excellent communication and interpersonal skills.Strong organization and time management 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.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 InsuranceDiscounted rate at Anytime FitnessFinancial Perks and DiscountsEstimated Annual Salary (dependent on experience) $95,000 - $113,000.
Equal Opportunity Employment StatementPSC 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.
#J-18808-Ljbffr
| Posted on 12/12/2023PSC 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 RoleWe are hiring an experienced and motivated Validation Engineer to support commissioning and qualification activities.Generate and execute CQPs, PQs, test plans, reports, and identify any potential associated issues or discrepancies for a variety of equipment and systems.Support all qualification execution and documentation reporting for fill lines, freezers, water baths, CIP/SIP stations for tanks and filter units, vial washers, tunnel sterilizers, and other related/required equipment and systems.Execute required Cx/IQ/OQ test plans.Generate required documentation including but not limited to system assessments, URS, specifications, and so on.Support test case execution and corrective actions.Work collaboratively with cross functional teams to drive project success and completion.Effectively communicate action items, risks, etc. to stakeholders.Additional responsibilities as required.Requirements
Bachelor's degree in related engineering discipline.5+ years of commissioning, qualification, and validation experience in the pharmaceutical industry.Experience in KNEAT validation is preferred.Experienced with fill line equipment.Strong knowledge of aseptic processing and sterilization validation.Strong knowledge of industry regulations and standards.Excellent technical writing skills.Detail oriented and strong commitment to quality.Excellent communication and interpersonal skills.Strong organization and time management 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.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 InsuranceDiscounted rate at Anytime FitnessFinancial Perks and DiscountsEstimated Annual Salary (dependent on experience) $95,000 - $113,000.
Equal Opportunity Employment StatementPSC 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.
#J-18808-Ljbffr