Validation Engineer
Validation Engineer
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1-3years
$ 85000 - 120000
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.
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.
- Responsible for performing the validation of equipment clean rooms fill lines utility systems facilities processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision preparing protocols independently analyzing test results and preparing technical reports.
- Contributes directly to the completion of validation projects through the development of validation schedules master plans validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing.
- Coordinates validation activities with and seeks team support from Validation Development Manufacturing Engineering Quality third Parties and other groups on validation projects to ensure validation projects are carried out on time and on budget.
- Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
- Reviews protocols reports and data tables generated by peers and contract personnel.Represents the department on crossfunctional project teams.
Requirements
- Bachelors degree from accredited institution in Science or Engineering
- 2 years of experience in Pharma or regulated industry
- Strong background and experience in Validation and GMP regulations.
- GAMP Experience
- Aseptic Fill Line Experience
- 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
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 Holiday
- Education Assistance
- Pet Insurance
- Discounted Fitness/Gym Rates
- Financial Perks and Discounts
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 from accredited institution in Science or Engineering 2+ years of experience in Pharma or regulated industry Strong background and experience in Validation and GMP regulations. GAMP Experience Aseptic Fill Line Experience 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.
Employment Type
Full Time
