Quality Engineer
Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
5years
Not Disclosed
Salary Not Disclosed
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 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 through 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.
- Complete ongoing training activities including standard operating procedures required meetings and so on.
- 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
- Bachelors degree in scientific or engineering discipline.
- 5 years or more of quality engineering experience in the pharmaceutical and/or medical device industry.
- 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 crossfunctional teams.
- Ability to work independently and lead validation projects.
- Basic skills in Microsoft Office Suite.
- Excellent technical writing skills.
- Strong analytical and problemsolving skills.
- Strong time management and organizational skills with the ability to coordinate multidepartmental tasks and deliverables.
Benefits
- 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.
- Discounted rate at Anytime and 24Hour 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 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.
Employment Type
Full Time
