- Drive overall process improvement projects, providing GMP expertise focused on process optimization.
- Responsible for technology transfers.
- Manage the entire life cycle of equipment procurement, including vendor evaluation, FAT, SAT, as well as commissioning, qualification, and validation support.
- Perform facility fit and gap analysis.
- Author critical documentation including risk assessment, OOS investigation, and process issues.
- Develop and maintain GMP manufacturing documentation including product impact assessments.
- Define and provide user requirements for process equipment and associated drug product equipment.
- Facilitate and participate in project meetings, decisions, milestone mapping, etc. effectively representing MSAT division.
- Collaborate closely with cross-functional teams to ensure project success and timely deliverables.
- Present data and reports to internal and external teams.
- Additional responsibilities as required.
- Bachelor's degree in related engineering or scientific discipline.
- 5+ years of experience in a Manufacturing Science & Technology role.
- Advanced experience in a GMP manufacturing environment.
- Ability to provide technical guidance and training within GMP manufacturing operations.
- Proven experience in technology transfers, including the drafting and development of process documentation and analyses.
- Strong knowledge of regulatory requirements and industry standards.
- Experience and knowledge of pharmaceutical manufacturing product development.
- Strong analytical and problem solving skills.
- Excellent communication and interpersonal skills.
- Ability to build strong relationships across departments.
- Strong time management and organizational skills, with the ability to coordinate multi-departmental tasks and deliverables.
- At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
- 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 Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
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MS&T Engineer - Pomona, United States - PSC Biotech
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 multi-cultural team, PSC Biotech 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 compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech, it's about more than just a job—it's about your career and your future.
Your Role
We are hiring a MS&T Engineer to drive the daily MS&T strategy and operations, support overall process improvement projects, and provide GMP support, focusing on process optimization.
Requirements
Benefits
Offering a full suite of benefits, PSC BiotechTM 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.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.
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