Validation Engineer
Validation Engineer
Posted on :
18-10-2024
Employer Active
1 Vacancy
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Jobs by Experience
5years
Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
18-10-2024
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 to form something truly special. When you decide 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 Validation Engineer.Successful candidates will be proactive motivated and capable of taking initiative to ensure the highest standards of quality and compliance.
- Lead and execute validation activities for equipment commissioning qualification and validation facility and new product buildouts.
- Collaborate with crossfunctional teams to ensure validation activities align with project timelines and quality standards.
- Develop implement and execute validation protocols (IQ OQ PQ) for required equipment and systems.
- Conduct system and impact assessments to determine validation requirements.
- Author and review user requirements specifications (URS) and other required validation documentation.
- Manage change controls to ensure compliance with regulatory requirements.
- Conduct risk analyses and implement improvement strategy and corrective and preventative actions.
- Generate and manage required technical documentation including protocols reports etc.
- Support vendor/contractor coordination.
- Additional responsibilities as required.
Requirements
- Bachelors degree or higher in related engineering discipline.
- Minimum of 5 years of experience in commissioning qualification and validation engineering in the pharma/life science industry.
- Experience with new product buildouts.
- Strong understanding of industry regulations and compliance (cGMP FDA etc.)
- Proven experience in risk and change control management.
- Experienced writing developing and executing IQ OQ PQ protocols.
- Experience in system and impact assessment.
- Strong understanding of engineering specifications (URS FS DS etc.)
- Project Management capabilities.
- Experience with cleanroom qualification and environmental monitoring is a plus.
- Experience with MasterControl is a plus.
- Excellent problemsolving skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proactive motivated and able to take initiative.
- 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
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more).
- Financial Perks and Discounts
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $90000 $140000 annually. The offered salary may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
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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Bachelors degree or higher in related engineering discipline. Minimum of 5 years of experience in commissioning, qualification, and validation engineering in the pharma/life science industry. Experience with new product build-outs. Strong understanding of industry regulations and compliance (cGMP, FDA, etc.) Proven experience in risk and change control management. Experienced writing, developing, and executing IQ, OQ, PQ protocols. Experience in system and impact assessment. Strong understanding of engineering specifications (URS, FS, DS, etc.) Project Management capabilities. Experience with clean-room qualification and environmental monitoring is a plus. Experience with MasterControl is a plus. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Proactive, motivated, and able to take initiative. 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.
Employment Type
Full Time
Key Skills
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