- Collaborate with cross-functional teams to gather/align information and gain thorough understanding of technical requirements.
- Write, develop, review, and approve technical documentation including but not limited to CQV protocols, user requirement specifications, functional specifications, equipment specification documentation, procedures, summary reports, and so on.
- Proactively ensure accuracy and completeness of all required technical documentation.
- Manage documentation updates and revisions.
- Execute required commissioning, qualification, and validation protocols for a range of specialty and process equipment.
- Conduct site and factory acceptance testing.
- Additional responsibilities as required.
- Bachelor's degree in related engineering discipline.
- 5+ years of experience in a technical writing role and experienced executing CQV activities.
- Experienced with process equipment, including but not limited to CTUs, bioreactors, lyophilizers, chrome skids, etc.
- Expererience in the peptide manufacturing space is a plus.
- Automation engineering background is a plus.
- Experienced with a range of technical writing software and systems.
- Knowledge of master controls.
- Excellent technical writing skills, with strong attention to detail and commitment to quality and compliance.
- Strong understanding of regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to hit the ground running and work both independently and collaboratively in a fast-paced environment with changing priorities and deadlines.
- Strong organizational and time-management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
- 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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Technical Writer - Carlsbad, 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 Technical Writer and Validation Engineer. This position will play a critical role in supporting multiple projects through technical writing, commissioning, qualification, and validation activities. Successful candidates are able to hit the ground running, possess effective communication skills, and a strong technical background.
Requirements
BenefitsOffering 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
Estimated annual salary (dependent on experience) $100,000 - $118,000
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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