PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client's success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer's expectations.
We are hiring mid-senior CQV Engineers. This is a hybrid position.Responsibilities
- Draft, review, and execute Master Validation Plan
- Conduct Factory Acceptance Testing and Site Acceptance Testing
- Assist all Installation Qualification, Performance Qualification, and Operational Qualification
- Draft, review, execute, and ensure accuracy in all required validation reports/documentation and requirement specification (URS, DS, FS)
- Clearly communicate all progress, updates, and action steps
- Ensure compliance with safety and quality standards
- Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or related from a 4-year university.
- 6-10 years of CQV experience for senior-level position
- 3-6 years of CQV experience for mid-level position
- Must have strong written and verbal communication skills
- Previous experience in GxP industries and Pharma and Device industries
- Experience performing commissioning, qualification, and validation on Pharma laboratory and manufacturing equipment
- IQ, OQ,PQ, experience
- Excellent technical writing skills
- Understands current risk-based validation approaches
- Thorough knowledge of cGMP guidelines
- Strong analytical and problem-solving skills
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 - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at 24 Hour Fitness
- Financial Perks and Discounts