Process Engineer

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, 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 job—it’s about your career and your future. Your Role The Process Engineer will be responsible for optimizing production processes by collaborating with various teams, developing solutions, and conducting risk assessments. The successful candidate will have experience in aseptic vial filling, lyophilization, process development, lab testing, and regulatory requirements in the pharmaceutical industry. Key tasks include designing and implementing process upgrades, ensuring safety and quality, and driving continuous improvement. C ollaborate with production managers and work with MSAT, R&D, Quality, Manufacturing, and Facilities teams to evaluate and enhance existing workflows, and implement new manufacturing capabilities, technologies, process automation, and control systems. Design and plan equipment layout for optimal production efficiency. Evaluate processes and equipment to ensure compliance with environmental and safety regulations. Analyze and interpret manufacturing process data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the manufacturing operations environment. Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Will assist manufacturing and quality when authoring Master Batch Records and implementing process improvements. Estimate production costs to aid in budgeting and financial planning. Perform other related duties as assigned. Requirements Bachelor's Degree in Engineering (Chemical Engineering preferred). 3-6 years of relevant experience in process engineering at a pharmaceutical company. Experience with LEAN/Six Sigma preferred. Experience in aseptic liquid and lyophilized drug product filling, process development, and lab testing. Proficiency in Minitab is a plus. Knowledge of GMPs, 21CFR, and other international regulatory requirements and guidelines. Excellent problem-solving skills with the ability to troubleshoot technical issues and implement effective solutions. Effective communication skills, both written and verbal, with the ability to present complex technical information to diverse audiences. Willingness to travel as needed 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