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 ExperienceWith 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 decide 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 RoleWe are seeking an experienced C&Q Engineer to support ongoing analytical instrumentation projects within a regulated life sciences environment. This individual will serve as the Equipment System Owner for commercial off-the-shelf (COTS), standalone computerized analytical instruments utilizing vendor-supplied proprietary software.
The ideal candidate will bring a strong combination of analytical testing experience and computerized equipment knowledge, with the ability to provide technical oversight throughout qualification activities. This role will focus primarily on reviewing and approving qualification documentation, participating in execution meetings, and providing system-owner oversight.
This is a primarily on-site position, with limited remote flexibility for documentation-related activities. Candidates must be authorized to work in the U.S.. We are unable to consider Corp-to-Corp (C2C) arrangements at this time.- Serve as the Equipment System Owner for computerized analytical instrumentation throughout commissioning and qualification activities.
- Provide technical ownership and oversight for COTS analytical instruments utilizing vendor-supplied proprietary software.
- Review qualification protocols, supporting documentation, and deliverables for technical accuracy and system-owner approval.
- Review and approve applicable project and qualification documentation.
- Participate in qualification execution meetings and provide system-owner input throughout project activities.
- Support equipment integration with network infrastructure for data storage while maintaining local instrument testing and operation.
- Provide expertise related to analytical instrumentation, computerized equipment, and associated data considerations.
- Collaborate with validation resources, engineering personnel, vendors, and other project stakeholders to support successful equipment qualification.
- Support issue resolution and provide technical input when questions arise during qualification activities.
- Maintain appropriate system-owner documentation throughout the project lifecycle.
- Facilitate an effective knowledge transfer and handoff to the designated long-term Equipment System Owner upon project completion.
Requirements- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline.
- 5-10 years of relevant professional experience supporting commissioning and qualification, analytical instrumentation, computerized equipment, or closely related activities within a regulated environment.
- Extensive experience working with analytical laboratory equipment and instrumentation.
- Demonstrated knowledge of computerized equipment utilizing vendor-supplied or proprietary software.
- Strong understanding of qualification documentation, including the ability to review and approve protocols and related deliverables.
- Experience serving as an Equipment System Owner, technical owner, or in a comparable equipment oversight capacity strongly preferred.
- Combination of analytical testing experience and computerized equipment experience strongly preferred.
- Experience working with standalone COTS systems and network-connected data storage environments preferred.
- Strong technical documentation review skills and attention to detail.
- Ability to effectively collaborate with validation teams, engineering groups, equipment vendors, and other cross-functional stakeholders.
- Ability to work primarily on-site, with limited remote work as appropriate for documentation activities.
- Ability to support a long-term project engagement and transition equipment ownership upon project completion.
- Must be authorized to work in the U.S.
- No C2C at this time.
BenefitsOffering 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, Long Term Disability and more
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
Adhering to the requirements of U.S laws on salary transparency, the base annual salary range expected for this role is set between $95,000 - $115,000. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment StatementPSC 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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