Location
Vista, CA | United States
Job description
PSC 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 multicultural 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 an experienced and driven Validation Engineer to support commissioning and validation projects as well as overall design support.
- Develop execute and review validation protocols ensuring compliance with regulatory requirements and industry standards.
- Support the development writing and review of specification documentation including URS FS and DS.
- Develop and implement construction control plans ensuring adherence to cGMP and regulatory requirements.
- Collaborate with the engineering team to provide validation input during the design phase of projects.
- Perform risk assessments and provide guidance to mitigate potential validation issues during construction.
- Validate utilities and process equipment to ensure they meet regulatory and company standards including but not limited to lyophilizers chrome skids controlled temperature units bioreactors and so on.
- Troubleshoot and resolve validationrelated issues with utilities and equipment.
- Prepare and maintain comprehensive validation documentation including protocols change controls reports and standard operating procedures (SOPs).
- Conduct factory acceptance testing when required.
- Additional responsibilities as required.
Requirements
- Bachelors Degree in engineering or related.
- 36 years of experience of validation commissioning and qualification engineering experience in the pharmaceutical manufacturing industry.
- Proven experience and success in developing specification documentation including URS FS DS etc.
- Background in supporting construction projects.
- Experienced conducting factory acceptance testing.
- Experienced in project design support ensuring that validation considerations are integrated into the design and implementation of new systems and processes.
- Experienced with utilities and process equipment (lyophilizers chrome skids controlled temperature units tanks bioreactors etc.)
- Advanced knowledge of industry regulations.
- Experience with automation controls is a plus.
- Excellent communication and collaboration skills.
- Detailoriented with a focus on ensuring compliance and quality.
- 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 is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
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
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Estimated Annual Salary (dependent on experience) $85000 $100000.
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 employersponsored 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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Bachelor\'s Degree in engineering or related. 3-6 years of experience of validation, commissioning, and qualification engineering experience in the pharmaceutical manufacturing industry. Proven experience and success in developing specification documentation including URS, FS, DS, etc. Background in supporting construction projects. Experienced conducting factory acceptance testing. Experienced in project design support, ensuring that validation considerations are integrated into the design and implementation of new systems and processes. Experienced with utilities and process equipment (lyophilizers, chrome skids, controlled temperature units, tanks, bioreactors, etc.) Advanced knowledge of industry regulations. Experience with automation controls is a plus. Excellent communication and collaboration skills. Detail-oriented with a focus on ensuring compliance and quality. 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 is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Job tags
Salary