Validation Technician
Validation Technician
Posted on :
19-11-2024
Employer Active
1 Vacancy
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Job Description
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 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
- Draft review and execute commissioning qualification and validation protocols for a range of required equipment and systems.
- Schedule and execute qualification activities.
- Draft review author and deploy all required validation documentation including IQ/OQ/PQ protocols reports master plans risk assessments operating procedures URS FRS and so on.
- Document and report all validation activities and results. Ensure documentation updates as needed.
- Perform risk assessments and develop mitigation strategies for equipment and processes as required.
- Analyze test results data and acceptance criteria to ensure accuracy.
- Ensure all validation and qualification activities are completed in compliance with industry standards and regulations.
- Attend meetings and coordinate project activities.
- Collaborate closely with crossfunctional teams to ensure alignment and successful project/deliverable execution.
- Additional responsibilities as required.
Requirements
- Bachelors degree in related engineering discipline.
- 4 plus years of commissioning qualification and Kfold validation experience in the pharmaceutical manufacturing industry.
- Handson experience with IQ OQ PQ execution including equipment like chambers freezers incubators refrigerators fill lines etc.
- Strong knowledge of aseptic processes and techniques.
- Strong knowledge of industry regulations and requirements.
- Excellent technical writing skills and experience with full life cycle validation documentation.
- Excellent communication and interpersonal skills.
- Strong analytical and problemsolving skills.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
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
- 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
Estimated annual salary (dependent on experience): $80000$90000
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.
#LITP1
Bachelor s degree in Information Technology, Computer Science, or a related field. A minimum of 4 years of experience in IT systems management, specifically in the R&D or clinical sector. Strong knowledge of IT change management processes. Experience in business analysis and project management is a plus. Experience with Veeva systems, particularly in clinical and regulatory environments. Proficiency in IT Service Management systems (e.g., ServiceNow), identity management tools, and integration technologies such as API-based solutions. Strong understanding of SDLC (System Development Life Cycle) processes, particularly in regulated environments. Experience with reporting tools (e.g., PowerBI) and relational databases. Excellent communication skills with the ability to collaborate effectively with cross-functional teams. Ability to work well in a fast-paced environment. Ability to work independently with minimal supervision. Effective interpersonal and communication skills. Able to support Pacific or Central Standard Times working hours.
Employment Type
Full Time
Key Skills
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