Jr. Computer Systems Validation Engineer
Posted on :
01-11-2022
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Job Description
This is a remote position.
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
We are hiring an junior-level Computer System Validation Engineer.The project duration is 1 to 3+ years, and will be supporting our US-Based with occasional regional or global travels and the opportunity to work remotely
Responsibilities
- Assist in generation and execution of validation documents (System Testing, IQ, OQ, PQ, UAT), for GxP and non-GxP computerized systems such as IT infrastructure, R&D (Pre-Clinical/Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance), Commercial (CRM, eCommerce), Supply Chain/ Manufacturing Operations / Quality (Labs, Labeling/Artwork, QMS, Change Management, Deviations & Investigations, Training), Finance, HR, Legal/Corporate Compliance.
- Assist in Development, implementation, and maintenance of computerized system s state of validation and compliance throughout its SDLC.
- Assist in working with system vendors and development teams to develop, harmonize, leverage, and support documentation( Specifications, Vendor/development testing, Reports, etc.)
- Assist in supporting computerized systems change management and periodic review processes.
- Assist in supporting regulatory inspections and internal and partner audits, and implement corrective actions as needed in
- Assist in the preparation of life cycle, validation, and project summary reports.
- Responsible for Migration/Conversion of documents from an existing system to a new system document standard and format.
- Meet with clients or management to understand data conversion/migration requirements and needs.
- Cleanse or translate data so that it can be effectively moved between systems.
- Other duties as assigned.
Requirements
- Knowledge of validation of cGxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations.
- Typing speed of 80+ wpm
- Effective written and oral communication skills.
- Excellent time management, interpersonal and problem-solving skills.
- Must demonstrate the ability to excel in a collaborative team-working environment.
- 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-TW1 #LI-REMOTE
Knowledge of validation of cGxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations. Typing speed of 80+ wpm Effective written and oral communication skills. Excellent time management, interpersonal and problem-solving skills. Must demonstrate the ability to excel in a collaborative team-working environment. Willingness to travel is preferred.
Employment Type
Full Time
Key Skills
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