Validation and Qualification Specialist III
2 weeks ago
PSC Biotech is dedicated to providing essential services to the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed to the highest standards while adhering to all relevant regulatory requirements.
Our mission is to elevate our clients' success, and you can contribute to our team's accomplishments. With a global workforce of skilled professionals and experts located in strategically positioned offices across North America, Europe, Asia, and the Middle East, we take pride in the roles we play in helping our clients achieve their goals.
The Experience
At PSC Biotech, we are passionate about uniting the best and brightest minds from diverse backgrounds to create something exceptional. By joining our team, you will have the opportunity to be inspired in your career, pursue your professional interests, and collaborate with individuals who appreciate and cultivate your talents.
We are committed to mentoring and developing the next generation of industry leaders and influencers. Therefore, you will receive not only a competitive compensation and benefits package but also the resources necessary for your growth and learning.
Your Role
We are seeking a qualified CQV Engineer III to oversee the commissioning, qualification, and validation processes for various equipment and systems within the pharmaceutical and/or medical device sectors.
- Lead the formulation and implementation of commissioning, qualification, and validation protocols for diverse equipment and systems.
- Draft, review, and finalize all necessary validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, and procedures.
- Provide technical guidance throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
- Assist with environmental monitoring tasks as needed.
- Identify potential risks and areas for improvement, proactively implementing risk mitigation strategies.
- Document test results, deviations, and investigations in accordance with company procedures and regulatory standards.
- Collaborate with cross-functional teams to ensure project timelines and deliverables are met, driving successful validation of critical systems and equipment.
- Contribute to the ongoing enhancement of validation processes and procedures.
- Ensure compliance with industry regulations and requirements at all times.
- Additional responsibilities as assigned.
Requirements
- Bachelor's degree in a relevant engineering discipline.
- A minimum of 7 years of experience in executing commissioning, qualification, and validation for various equipment within the pharmaceutical and/or medical device industries.
- Familiarity with regulatory requirements (cGMP, FDA, etc.).
- Strong problem-solving, analytical, and technical skills, with the ability to troubleshoot effectively.
- Excellent time management and organizational skills.
- Effective communication and interpersonal abilities.
- Detail-oriented with a commitment to maintaining high-quality standards.
- Ability to work independently as well as part of a team.
Benefits
PSC Biotech offers a comprehensive benefits package, focusing on investing in our employees who enable our company to fulfill its mission and achieve success. We promote a healthy work-life balance, ensuring you enjoy your work while having the time and resources to live a fulfilling life.
- Medical, Dental, and Vision - PSC covers 100% of 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) plan with matching contributions.
- Paid Time Off, Sick Leave, and Paid Holidays.
- Education Assistance programs.
- Pet Insurance options.
- Discounted memberships at fitness centers.
- Financial perks and discounts.
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