Quality Validation Specialist
Quality Validation Specialist
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5years
$ $ 85000 - 120000
1 Vacancy
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 to form something truly special. When you decide 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.
Your Role
We are hiring an experienced Quality Validation Specialist to support the commissioning qualification and validation for a range of equipment and systems within the pharmaceutical and biotechnology industries.
- Lead the development and execution of commissioning qualification and validation protocols for required equipment.
- Draft review author and deploy all required validation documentation including IQ/OQ/PQ protocols reports master plans risk assessments procedures reports URS FRS and so on.
- Provide technical expertise throughout the validation lifecycle including risk assessment deviation investigation and change control activities.
- Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
- Document test results deviations and investigations in compliance with company procedures and regulatory standards.
- Collaborate with cross functional teams to support all project timelines and deliverables and be able to drive successful validation of critical systems and equipment.
- Contribute to the continuous improvement of validation processes procedures and projects.
- Manage projects from initiation to completion ensuring compliance with regulatory requirements and company standards.
- Ensure compliance with industry regulations and requirements at all times.
- Additional responsibilities as required.
Requirements
- Bachelors degree in related engineering discipline.
- 5 years of experience executing commissioning qualification and validation for a range of facilities equipment and systems within the pharmaceutical and/or biotechnology industries.
- Strong knowledge of regulatory requirements (cGMP FDA etc.).
- Proven experience with process equipment validation and qualification.
- Proficiency in plasma fractionation and purification processes.
- Project management capabilities/experience or certification preferred.
- Excellent problemsolving analytical and technical skills. Ability to problemsolve and troubleshoot effectively.
- Strong time management and organizational abilities.
- Effective communication and interpersonal skills.
- Detailoriented mindset with a commitment to maintaining highquality standards.
- Ability to work independently and as part of a team.
- Proactive motivated and able to take initiative.
- 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 Holiday
- Education Assistance
- Pet Insurance
- Discounted Fitness/Gym Rates
- 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.
#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
