- Lead commissioning and qualification efforts on various projects within the pharmaceutical manufacturing environment.
- Develop and execute commissioning and qualification strategies, protocols, and documentation for pharmaceutical manufacturing systems and equipment.
- Provide technical expertise and guidance to project teams to ensure compliance with industry regulations and company standards.
- Identify and assess risks associated with commissioning and qualification activities, and develop mitigation strategies. Implement best practices and continuous improvement initiatives.
- Generate comprehensive commissioning and qualification documentation, including protocols, reports, and summary documents.
- Work efficiently and collaboratively with cross-functional teams to drive project completion and deliverables.
- Additional responsibilities as required.
- Bachelor's degree in related engineering discipline.
- 7+ years of commissioning and qualification engineering experience within the pharmaceutical industry.
- Background and expertise must include direct experience with all or some of the following: utilities and facilities C&Q projects, drug substance/drug product equipment, audio-visual inspection systems, cleaning systems (CIP/SIP), and/or temperature mapping.
- In-depth knowledge of regulatory requirements and industry standards applicable to pharmaceutical manufacturing
- Strong problem-solving and analytical skills, with the ability to troubleshoot and resolve complex technical issues.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a cross-functional team environment.
- Ability to manage multiple tasks and priorities effectively.
- Detail-oriented with a commitment to producing high-quality work.
- 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
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Commissioning and Qualification Engineer - Thousand Oaks, United States - PSC Biotech
Description
Job DescriptionPSC 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 multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision 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 firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech, it's about more than just a job-it's about your career and your future.
Your Role
We are hiring experienced and well-rounded Commissioning and Qualification Engineers. Engineers will lead and support commissioning and qualification activities across a wide range of projects. Successful candidates should have a strong background in the life sciences/pharmaceutical industry, being well-versed in a range of equipment and systems including but not limited to facilities, utilities, drug substance/drug product equipment, audio-visual inspection systems, and/or cleaning systems.
Offering a full suite of benefits, PSC BiotechTM 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.
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 employer-sponsored 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.
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