Validation Engineer
Validation Engineer
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2-5years
85000 - 100000
1 Vacancy
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.
Your Role
We are hiring experienced motivated and handson engineers experienced in commissioning qualifying and validating pharmaceutical manufacturing facilities utilities equipment and systems. Our engineers play a critical role in driving project success through developing and executing protocols identifying and mitigating risks operating and troubleshooting equipment and generating project lifecycle documentation while ensuring regulatory standards and quality compliance.
- Develop and execute commissioning qualification and validation protocols for required equipment and systems.
- Generate review and/or author all required technical documentation including IQ/OQ/PQ protocols operating procedures specifications (URS FS DS) risk assessments reports and so on.
- Collaborate with crossfunctional teams to ensure validation activities are aligned with project timelines and regulatory requirements.
- Conduct risk assessments impact assessments and gap assessments identifying potential risks and implementing mitigation strategies.
- Analyze test results data and acceptance criteria to ensure accuracy.
- Troubleshoot and operate required equipment to support startup activities and evaluate process performance. Ensure appropriate equipment/system modifications as needed.
- Additional responsibilities as required to drive project deliverables.
Requirements
- Bachelors degree in related engineering discipline.
- 25 years of experience executing commissioning qualification and validation for a range of equipment and systems within the pharmaceutical and/or biotechnology industries.
- Experienced writing and generating technical validation documentation including IQOQPQ protocols specifications (URS FS DS) operating procedures etc.
- Proven knowledge of regulatory requirements and industry standards (cGMP FDA etc.).
- Strong understanding of riskbased validation approach.
- Proactive and motivated with the ability to manage multiple tasks /projects.
- Excellent problemsolving analytical and technical skills.
- Strong time management and organizational abilities.
- Effective communication and interpersonal skills.
- Detailoriented mindset with a commitment to maintaining highquality standards.
- Ability to work independently and as part of a team.
Benefits
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 related engineering discipline. 2-5 years of experience executing commissioning, qualification, and validation for a range of equipment and systems within the pharmaceutical and/or biotechnology industries. Experienced writing and generating technical validation documentation including IQOQPQ protocols, specifications (URS, FS, DS), operating procedures, etc. Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.). Strong understanding of risk-based validation approach. Proactive and motivated with the ability to manage multiple tasks /projects. Excellent problem-solving, analytical, and technical skills. Strong time management and organizational abilities. Effective communication and interpersonal skills. Detail-oriented mindset with a commitment to maintaining high-quality standards. Ability to work independently and as part of a team.
Education
Bachelor's Degree in Related Fields
Employment Type
Full Time
