drjobs Validation Engineer II

Validation Engineer II

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5-7 سنوات

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الوصف الوظيفي

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

  • Development / execution / closure of validation deliverables.
  • Requalification/Qualification of Autoclaves, Ovens, and process equipment.
  • Author and execute requalification protocols, IQ s, OQ s, and PQ s as necessary.
  • Revise validation controlled documents as necessary.
  • Work cross-functionally with Engineering, Manufacturing and Quality to perform scheduled work and complete assigned projects.
  • Other duties as assigned.


Requirements

  • 3+ years of Validation experience.
  • Must be familiar with good documentation practices (GDP) and cGMP environment.
  • Autoclave experience is required.
  • Experience with Kaye Validator AVS (preferred) or Kaye Validator 2000.
  • Experience with Blue Mountain Regulatory Asset Manager (BMRAM) is preferred.
  • Excellent Technical Writing Skills.
  • Ability and willingness to travel is preferred.


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 - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
  • 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

3+ years of Validation experience. Must be familiar with good documentation practices (GDP) and cGMP environment. Experience with Autoclave Qualification. Experience with Kaye Validator AVS (preferred) or Kaye Validator 2000. Experience with Blue Mountain Regulatory Asset Manager (BMRAM) is preferred. Knowledge of Sterilization Practices. Excellent Technical Writing Skills. Ability and willingness to travel is preferred.

نوع التوظيف

دوام كامل

نبذة عن الشركة

0-50 موظف
الإبلاغ عن هذه الوظيفة
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل. نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا