What are the responsibilities and job description for the Validation Project Engineer position at PSC Biotech?
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 motivated and experienced Validation Project Engineer to join our team. The ideal candidate will possess a strong technical background in engineering, validation processes, quality, and project management, coupled with excellent interpersonal and communication skills. The Validation Project Engineer will play a crucial role in ensuring the successful execution of validation projects while actively supporting customer success, client engagement, and business development efforts.
- Lead validation projects from initiation to completion, ensuring compliance with regulatory requirements and company standards. Develop project plans, schedules, and budgets, and track progress against milestones.
- Develop and execute validation protocols and maintain accurate and up-to-date project documentation.
- Identify opportunities for process optimization and efficiency improvements within validation projects. Proactively seek innovative solutions to enhance validation processes and overall project execution.
- Identify and proactively manage project risks. Develop mitigation plans and contingency strategies to address potential issues.
- Drive effective client engagement, customer success, and provide effective business development support.
- Meet with stakeholders, existing, and new customers to support the overall success of business needs and growth.
- Effectively develop and maintain outreach strategies and customer inquiries, providing technical expertise to support customer success initiatives.
- Collaborate with the sales team to understand customer needs and contribute technical insights during the sales process.
- Provide technical expertise and support to cross-functional teams overall.
- Foster a collaborative and positive team environment.
- Additional responsibilities as required.
Requirements
- Bachelor's degree in engineering or related.
- 5-10 years of engineering experience within the life science, pharmaceutical, biotech, and/or medical device industry.
- Advanced technical background coupled with strong analytical skills to be able to effectively identify risks, areas of improvement, and provide/execute efficient solutions.
- Strong knowledge of industry regulations and compliance.
- In-depth QC/QA background.
- CDMO experience is a plus.
- Strong project management skills with a successful track record of managing multiple complex projects.
- Excellent communication and interpersonal skills with the ability to work collaboratively with stakeholders, customers, and across departments.
- Demonstrated ability to balance technical requirements with business objectives.
- Excellent organization and time management skills.
- Strong negotiation technique.
- Travel is required.
Benefits
Offering a full suite of benefits, PSC Biotech™ 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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