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Validation Engineer
•27 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Rockville, Maryland |
About this job
Job Description
Job Description
Requirements
Benefits
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
- Act as lead and simplify CQV functions, reports, and processes.
- Support implementing safety programs for major capital projects.
- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Initiate, author, revise, review and complete controlled documents for CQV projects.
- Review and qualify equipment for commissioning, qualification, and validation activities.
- Write and review GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, PQ, and OQ.
- Contact and work with contractors and vendors on assigned projects.
- Ability to travel as needed.
- Additional duties and responsibilities may be assigned from time-to-time.
Requirements
- Bachelors degree in Engineering or Life Sciences.
- 5-7 years of applicable work experience in the biomedical and pharmaceuticals industry.
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, and PV documents.
- Proficient in developing SOPs, final reports, and validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Good understanding and complies with cGMPs and CFR21 part 11 guidelines.
- Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans; demonstrated ability to develop and implement marketing and product/service strategies by converting into tactical marketing plans; execute and deliver results
- Excellent presentation and communication skills, written and oral, for a variety of audiences.
- Highly organized in planning and time management, with the ability to multi-task.
- 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.
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