Quality Validation Engineer

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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.

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 experienced and motivated Quality Engineer. This position requires a strong background and understanding of validation processes and procedures to provide technical expertise and thorough quality review of validation documentation and corrections. The Quality Engineer plays a critical role in ensuring project success and compliance with industry regulations.

• Provide thorough quality review and approval of required validation lifecycle documentation including commissioning qualification validation protocols reports records etc.
• Provide ongoing technical guidance and expertise ensuring compliance with industry standards and regulations.
• Review and approve specified documentation including technical specifications vendor supplied test results design qualification test plans RTM changes and exceptions.
• Provide guidance on interpretation and application of specified requirements.
• Effectively communicate project updates and milestones with project stakeholders.
• Provide guidance and suggestions on technical aspects for improvement.
• Ensure efficient followup to crossfunctional departments and QA team.
• Identify errors risks and potential documentation issues ensuring accuracy and compliance in required documentation processes. Effectively mitigate and recommend improvement.
• Stay abreast of current regulatory requirements and industry trends providing guidance on compliance matters.
• Additional responsibilities as required.

Requirements

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.

Estimated Annual Salary (dependent on experience) $95000 $130000

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 scientific or engineering discipline. 5 years or more of quality engineering experience in the pharmaceutical and / or medical device industry. Plastic & Polymers molding / injecting experience strongly preferred. Able to travel for up to 25% to meet with clients and vendors. Strong understanding of regulatory requirements. Strong knowledge of commissioning, qualification, and validation engineering lifecycle documentation. Excellent attention to detail and quality background to provide thorough review and approval of validation lifecycle documentation. Strong understanding of regulatory compliance and industry requirements. Excellent communication and interpersonal skills for effective collaboration with cross-functional teams. Ability to work independently and lead validation projects. Basic skills in Microsoft Office Suite. Excellent technical writing skills. Strong analytical and problem-solving skills. Strong time management and organizational skills, with the ability to coordinate multi-departmental tasks and deliverables.

Key Skills

Python,SOC,Debugging,C / C ,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Experience : 5 years

Vacancy : 1

Monthly Salary Salary : $ 100000 - 130000

Salary : $100,000 - $130,000