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Posted : Wednesday, April 03, 2024 06:12 AM
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 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 well-rounded Validation Engineer.
The position will play a key role in ensuring critical validation processes are in compliance with regulatory guidelines, and contribute to driving overall project success.
The successful candidate should have hands-on experience with sterilization, filling lines, SIP, cleaning validation, and strong technical writing skills to support required documentation.
Develop and implement validation plans, protocols, and reports for equipment, processes, and systems in accordance with regulatory guidelines and company standards.
Collaborate with cross-functional teams to ensure validation activities align with project timelines and objectives.
Execute IQ/OQ/PQ protocols for equipment, utilities, and facilities.
Perform risk assessments and impact analyses to determine validation requirements.
Plan, execute, and document SIP activities for pharmaceutical manufacturing processes.
Support cleaning validation activities for equipment and facilities.
Support the validation of transfer panels and filling lines.
Generate comprehensive and accurate validation documentation, including test scripts, summary reports, and deviation reports.
Maintain detailed records of all validation activities in compliance with regulatory standards.
Identify areas for process improvement and work collaboratively to implement enhancements.
Additional responsibilities as required.
Requirements Bachelors degree in Engineering.
5+ years of hands-on validation engineering experience in the pharmaceutical industry.
Advanced knowledge and understanding of regulatory requirements and industry standards (FDA, EMA, cGMP, etc.
).
Strong understanding of cleaning validation, sterilization, SIP, and associated processes.
Experience with filling lines.
Experience with transfer panels.
Strong knowledge of User Requirement Specifications, Functional Requirement/Design Specifications.
Excellent technical writing skills, advanced experience drafting validation documentation.
Knowledge of risk assessment methodologies.
Strong analytical and problem-solving skills, with a keen attention to detail.
Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to both technical and non-technical stakeholders.
Ability to work independently and collaboratively in a fast-paced environment.
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 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 Bachelor's degree in Engineering.
3-5+ years of hands-on validation engineering experience in the pharmaceutical industry.
Advanced knowledge and understanding of regulatory requirements and industry standards (FDA, EMA, cGMP, etc.
).
Strong understanding of cleaning validation, sterilization, SIP, and associated processes.
Experience with filling lines.
Experience with transfer panels.
Strong knowledge of User Requirement Specifications, Functional Requirement/Design Specifications.
Excellent technical writing skills, advanced experience drafting validation documentation.
Knowledge of risk assessment methodologies.
Strong analytical and problem-solving skills, with a keen attention to detail.
Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to both technical and non-technical stakeholders.
Ability to work independently and collaboratively in a fast-paced environment.
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.
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 well-rounded Validation Engineer.
The position will play a key role in ensuring critical validation processes are in compliance with regulatory guidelines, and contribute to driving overall project success.
The successful candidate should have hands-on experience with sterilization, filling lines, SIP, cleaning validation, and strong technical writing skills to support required documentation.
Develop and implement validation plans, protocols, and reports for equipment, processes, and systems in accordance with regulatory guidelines and company standards.
Collaborate with cross-functional teams to ensure validation activities align with project timelines and objectives.
Execute IQ/OQ/PQ protocols for equipment, utilities, and facilities.
Perform risk assessments and impact analyses to determine validation requirements.
Plan, execute, and document SIP activities for pharmaceutical manufacturing processes.
Support cleaning validation activities for equipment and facilities.
Support the validation of transfer panels and filling lines.
Generate comprehensive and accurate validation documentation, including test scripts, summary reports, and deviation reports.
Maintain detailed records of all validation activities in compliance with regulatory standards.
Identify areas for process improvement and work collaboratively to implement enhancements.
Additional responsibilities as required.
Requirements Bachelors degree in Engineering.
5+ years of hands-on validation engineering experience in the pharmaceutical industry.
Advanced knowledge and understanding of regulatory requirements and industry standards (FDA, EMA, cGMP, etc.
).
Strong understanding of cleaning validation, sterilization, SIP, and associated processes.
Experience with filling lines.
Experience with transfer panels.
Strong knowledge of User Requirement Specifications, Functional Requirement/Design Specifications.
Excellent technical writing skills, advanced experience drafting validation documentation.
Knowledge of risk assessment methodologies.
Strong analytical and problem-solving skills, with a keen attention to detail.
Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to both technical and non-technical stakeholders.
Ability to work independently and collaboratively in a fast-paced environment.
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 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 Bachelor's degree in Engineering.
3-5+ years of hands-on validation engineering experience in the pharmaceutical industry.
Advanced knowledge and understanding of regulatory requirements and industry standards (FDA, EMA, cGMP, etc.
).
Strong understanding of cleaning validation, sterilization, SIP, and associated processes.
Experience with filling lines.
Experience with transfer panels.
Strong knowledge of User Requirement Specifications, Functional Requirement/Design Specifications.
Excellent technical writing skills, advanced experience drafting validation documentation.
Knowledge of risk assessment methodologies.
Strong analytical and problem-solving skills, with a keen attention to detail.
Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to both technical and non-technical stakeholders.
Ability to work independently and collaboratively in a fast-paced environment.
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.
• Phone : NA
• Location : Waco, TX
• Post ID: 9002139939
