Validation Engineer
5 days ago
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 multicultural 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 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 crossfunctional 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
- Bachelors degree in relevant engineering discipline.
- 5 years of validation experience in the pharmaceutical manufacturing industry.
- Indepth 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.)
- Detailoriented 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 problemsolve 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 24Hour 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 employersponsored 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.
#LIRW1
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