Commissioning Qualification Validation Engineer
Commissioning Qualification Validation Engineer
Posted on :
19-09-2024
Employer Active
1 Vacancy
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Jobs by Experience
3-5years
Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
19-09-2024
Job Description
The work we do at BioTechnique has never been more important and we are looking for talented candidates to join us. We re growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in people s lives. Join BioTechnique and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here you ll work alongside and learn from some of the most dedicated scientists engineers and manufacturers in the industry. We re proud to cultivate a culture that will fuel your passion energy and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique you determine what s possible.
BioTechnique is a highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fillfinish services. BioTechnique s project management and client services staff work closely with our clients to meet all manufacturing needs. From IND applications through commercial scale production we provide formulation and compounding fillfinish and optional lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to work with our clients to create a process design for their product that suits their needs.
The Experience
With operations spanning the globe and featuring a multicultural team BioTechnique 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 a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At BioTechnique it s about more than just a job it s about your career and your future.
Your Role
The Commissioning Qualification and Validation (CQV) Engineer will play a crucial role in ensuring the successful commissioning qualification and validation of equipment facilities processes and systems to meet regulatory requirements and quality standards and responsible for ensuring systems facilities and equipment meet design requirements. The incumbent is also responsible and accountable for the of the PSC mission to maintain the integrity and professionalism of our products and services while enabling steady growth and development."
- Collaborate with project teams to develop commissioning and qualification strategies.
- Participate in the design development and of commissioning and qualification protocols ensuring alignment with regulatory requirements and industry best practices.
- Responsible for the authoring reviewing revising and writing of validation controlled documents in assigned projects. Develop validation master plans protocols and reports to ensure compliance with relevant regulations and standards.
- Commission qualify and validate facilities utilities and/or equipment in assigned projects.
- Assist to initiate and coordinate risk analyses design reviews execute FAT/SAT IQ OQ and PQ.
- Collaborate with crossfunctional teams to implement risk mitigation strategies and continuous improvement initiatives.
- Maintain accurate and organized documentation of all commissioning qualification and validation activities ensuring traceability and accountability.
- Contact and work with contractors and vendors on assigned projects.
- Drive continuous improvement initiatives related to validation processes methodologies and documentation practices.
- Additional duties and responsibilities may be assigned from time to time.
Requirements
- Bachelor s Degree in Engineering.
- 35 years of applicable work experience in commissioning qualifying and validating facilities equipment and utilities within the pharmaceutical manufacturing industry or related.
- Strong understanding of regulatory requirements (FDA EU etc.) and industry standards (GMP ISO CFR21 etc.).
- KNEAT validation experience and/or certification is preferred.
- Handson experience with commissioning qualification and validation protocols and documentation including SOPs final reports master plans etc.
- Proficiency in risk assessment methodologies and tools.
- Experience authoring and executing DQ FAT SAT IQ OQ PQ and PV documents.
- Detailoriented with a strong commitment to quality and compliance.
- Excellent analytical and problemsolving skills.
- Strong communication skills verbal and written.
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.
#LIFF1
Bachelor s Degree in Engineering. 3-5 years of applicable work experience in commissioning, qualifying and validating facilities, equipment, and utilities within the pharmaceutical manufacturing industry or related. Strong understanding of regulatory requirements (FDA, EU, etc.) and industry standards (GMP, ISO, CFR21, etc.). KNEAT validation experience and/or certification is preferred. Hands-on experience with commissioning, qualification, and validation protocols, , and documentation including SOPs, final reports, master plans, etc. Proficiency in risk assessment methodologies and tools. Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents. Detail-oriented with a strong commitment to quality and compliance. Excellent analytical and problem-solving skills. Strong communication skills, verbal and written. 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. #LI-FF1
Employment Type
Full Time
Key Skills
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