What are the responsibilities and job description for the Validation Engineer position at PSC Biotech Corporation?
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.
The Experience
With operations spanning the globe and featuring a multi-cultural team, BioTechnique 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 a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring a highly motivated and experienced Validation Engineer to join our team in York, PA. This role will ensure that all manufacturing processes and equipment are validated and operate in compliance with regulatory standards, while implementing effective process improvements.
Offering a full suite of benefits, BioTechnique 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.
BioTechnique 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.
The Experience
With operations spanning the globe and featuring a multi-cultural team, BioTechnique 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 a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring a highly motivated and experienced Validation Engineer to join our team in York, PA. This role will ensure that all manufacturing processes and equipment are validated and operate in compliance with regulatory standards, while implementing effective process improvements.
- Develop and execute validation protocols (IQ, OQ, PQ) for pharmaceutical manufacturing processes, equipment, and systems.
- Conduct risk assessments, root cause analysis, and deviation investigations. Implement risk mitigation and solutions for improvement, ensuring compliance with regulatory requirements.
- Analyze data to identify trends, deviations, and areas for improvement.
- Troubleshoot and resolve issues related to equipment and process performance.
- Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
- Collaborate with cross-functional teams to ensure alignment on validation activities and project timelines.
- Support the mentoring and coaching junior level team members.
- Additional responsibilities as assigned.
- Bachelor's degree in relevant engineering or scientific discipline.
- 3-5 years of proven validation experience in the pharmaceutical manufacturing industry.
- Advanced knowledge of regulatory requirements and guidelines.
- Strong technical writing skills and knowledge of full lifecycle documentation.
- Excellent problem-solving and analytical skills.
- Excellent communication and interpersonal skills.
- Attention to detail and commitment to quality and compliance.
- Proactive with strong organization, time management, and project management abilities.
Offering a full suite of benefits, BioTechnique 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 - BioTechnique 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
BioTechnique 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.
