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Validation Quality Engineer
2 months ago
PSC Biotech is dedicated to providing essential services within the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed in accordance with the highest standards and regulatory requirements.
Our Mission
Our aim is to elevate our clients' success, and you can contribute to our achievements. With a global team of skilled professionals across strategically located offices, we take pride in the roles we have played in our clients' success.
The Opportunity
At PSC Biotech, we are passionate about assembling a diverse and talented team. By joining us, you will find inspiration in your career, explore your professional interests, and collaborate with individuals who appreciate and cultivate your skills.
Your Responsibilities
We are seeking a qualified and driven Quality Engineer. This role necessitates a solid understanding of validation processes and procedures to provide technical expertise and comprehensive quality review of validation documentation. The Quality Engineer is pivotal in ensuring project success and adherence to industry regulations.
- Conduct thorough quality reviews and approvals of essential validation lifecycle documentation, including commissioning, qualification, and validation protocols.
- Offer ongoing technical guidance and expertise, ensuring compliance with industry standards and regulations.
- Review and approve specified documentation such as technical specifications, vendor test results, design qualifications, and test plans.
- Provide insights on the interpretation and application of specified requirements.
- Engage in continuous training activities, including standard operating procedures and required meetings.
- Effectively communicate project updates and milestones to stakeholders.
- Propose guidance and suggestions for technical improvements.
- Ensure efficient follow-up with cross-functional departments and the QA team.
- Identify errors, risks, and potential documentation issues, ensuring accuracy and compliance in documentation processes.
- Stay informed about current regulatory requirements and industry trends, providing guidance on compliance matters.
- Perform additional responsibilities as needed.
Qualifications
To be considered for this role, candidates should possess:
- A Bachelor's degree in a scientific or engineering discipline.
- A minimum of 3 years of quality engineering experience in the pharmaceutical or medical device industry.
- A strong understanding of regulatory requirements.
- In-depth knowledge of commissioning, qualification, and validation engineering lifecycle documentation.
- Exceptional attention to detail and a quality-oriented background for thorough review and approval of validation documentation.
- Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
- The ability to work independently and lead validation projects.
- Basic proficiency in Microsoft Office Suite.
- Strong technical writing skills.
- Robust analytical and problem-solving abilities.
- Effective time management and organizational skills, capable of coordinating multi-departmental tasks.
Benefits
PSC Biotech offers a comprehensive benefits package, emphasizing our commitment to investing in our employees who drive our mission forward. We strive to promote a healthy work-life balance, ensuring you have the resources to live a fulfilling life.
- Medical, Dental, and Vision coverage with PSC covering 100% of qualifying employee medical premiums and 50% for qualifying dependents.
- Insurance options including Employee Assistance Programs and Basic Life Insurance.
- Short and Long Term Disability coverage.
- 401(k) plan with matching contributions.
- Paid Time Off, Sick Leave, and Paid Holidays.
- Education Assistance programs.
- Pet Insurance options.
- Discounted rates at fitness centers.
- Financial perks and discounts.
Equal Opportunity Employment Statement
PSC is committed to a policy of Equal Employment Opportunity for all employees, interns, and applicants. We comply with all applicable federal, state, and local laws regarding employment discrimination.
