- Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
- Generate and manage project plans, preventative maintenance coordination, and risk mitigation.
- Oversee validation projects from initiation to completion.
- Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
- Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
- Provide ongoing support and technical expertise through validation execution and qualification activities.
- Conduct risk analyses and identify potential risks, recommending areas of improvement.
- Perform risk assessments to identify critical process parameters and develop mitigation strategies.
- Ensure all validation activities comply with FDA, EMA, and other relevant regulatory bodies.
- Additional responsibilities as required.
- Bachelor's degree in related engineering discipline.
- 5+ years of validation engineering experience in the pharmaceutical/life science industry.
- Experienced in paperless validation, preferably ValGenesis.
- Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
- Strong understanding of engineering specifications and requirements.
- Experienced generating and executing Validation activities on a range of equipment and systems.
- Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
- Excellent technical writing skills.
- Strong understanding of industry regulations and requirements.
- Excellent communication and interpersonal skills.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- 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.
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Validation Project Engineer - Indianapolis, United States - PSC Biotech
Description
Job Description
Job DescriptionPSC 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 an experienced Validation Project Engineer. Successful candidates will have a strong technical background in equipment/system validation coupled with excellent communication, organization, and project coordinating capabilities.
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.
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
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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