- Support all DQP project implementation tasks.
- Develop and maintain comprehensive documentation. Author document templates to guide the creation of future equipment procedures and forms.
- Support all technical writing requirements including but not limited to SOPs for analytical equipment and systems, calibration, qualification, and maintenance.
- Collaborate with laboratory personnel to ensure proper calibration, validation, and functionality of analytical instruments.
- Author and review instrument procedures.
- Develop equipment binders.
- Work closely with third party vendors, scheduling equipment qualifications for remediation work.
- Implement user access controls and audit trails.
- Update equipment maintenance system to include information required per DQP implementation project.
- Ensure effective communication and frequent reports with team members and stakeholders regarding all project/deliverable progress, issues, risks, upcoming requirements, and so on.
- Attend weekly project meetings as needed.
- Identify opportunities for process improvement within the non-GMP labs and contribute to the implementation of best practices.
- Ensure adherence to regulatory requirements and internal quality standards.
- Bachelor's degree in engineering or related technical field.
- Minimum of 3+ years of engineering and technical writing experience with analytical equipment.
- Must possess knowledge of USP 1058.
- Excellent technical writing skills.
- Must have extensive experience with analytical equipment and systems.
- Experience writing operating procedures for analytical equipment including calibration, qualification, and maintenance.
- Strong understanding of regulatory requirements.
- Ability to work independently and manage daily activities in order to drive project completion and success.
- Excellent communication and coordination skills.
- Strong time-management with the ability to meet tight deadlines.
- Flexible - willing to work overtime when required.
- 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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Engineer - Durham, United States - PSC Biotech
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 Engineer to support the implementation of Development Quality Practices (DQP). Successful candidates will have excellent technical writing skills to be able to support operating procedures for analytical equipment, including calibration, qualification, and maintenance of systems and equipment.
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.
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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