Job Description Your Role We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.
- Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
- Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
- Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
- Troubleshoot and resolve issues related to equipment and process performance.
- Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.
- Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
- Additional responsibilities as required to drive successful validation project deliverables.
Requirements- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 2-7 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
- Strong knowledge of regulatory requirements and industry standards.
- Experience with validation lifecycle management and risk-based approaches.
- Excellent analytical and technical problem solving skills.
- Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
- Effective communication and interpersonal skills.
- Proactive with strong organization, time management, and project management abilities.
- Excellent attention to detail with commitment to quality and compliance.
- 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 are essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
- Must be authorized to work in the US.
- No C2C at this time.
BenefitsOffering 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 Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $100,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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