The work we do at BioTechnique has never been more importantand we are looking for talented candidates to join us. We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven 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 fill-finish 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, fill-finish, 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 multi-cultural 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 jobit'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 execution 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 execution 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 cross-functional 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.
- 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, execution, 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.
