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 ExperienceWith 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 Validation Engineer to support multiple validation projects. This role will be supporting second shift hours.
- Create and implement IQ, OQ, and PQ protocols, test methods, procedures, reports, and risk assessments for various pharmaceutical and manufacturing equipment, facilities, utilities, and systems.
- Contribute to the development of master plans and validation strategies for a variety of processes, adhering to regulatory requirements and compliance.
- Work collaboratively with cross-functional teams to ensure alignment and successful completion of validation activities and deliverables.
- Provide support for regulatory inspections as needed.
- Identify potential risks/issues throughout validation lifecycle, effectively supporting change controls.
- Conduct periodic reviews and requalification assessments as needed.
- Ensure all required documentation is reviewed, approved, stored, and managed accurately.
- Collaborate with vendors and contractors to ensure that equipment and systems meet validation requirements and specifications.
- Drive continuous improvement initiatives to enhance validation processes, documentation practices, and compliance standards across the organization.
- Additional responsibilities as required to drive successful project completion.
Requirements
- Bachelor's degree in relevant engineering discipline.
- 5+ years of validation experience in the pharmaceutical manufacturing industry.
- In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc.
- Experienced with validation of pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems.
- Advanced understanding of validation principles and methodologies.
- Excellent technical writing skills. 5+ years of experience drafting, developing, reviewing, and authoring technical documentation including protocols, procedures, risk assessment, specification requirements, etc.
- Strong understanding of engineering specifications (URS, DS, FS, etc.)
- Detail-oriented with a focus on accuracy and compliance.
- Ability to manage multiple priorities and prioritize tasks effectively.
- Excellent communication and interpersonal skills.
- Must be willing to work second shift.
- Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
BenefitsOffering 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