Job Description
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 As a Technical Writer within our pharmaceutical manufacturing operations, you will play a pivotal role in bridging the gap between complex scientific processes and clear, actionable documentation. You will be responsible for producing, revising, and maintaining a wide range of technical documents, including but not limited to standard operating procedures (SOPs), batch records, validation protocols, technical reports, and regulatory submissions.
- Develop, author, and edit high-quality documentation to support manufacturing processes, validation, quality, and regulatory compliance.
- Collaborate closely with subject matter experts, including scientists, engineers, and quality professionals to gather information and ensure technical accuracy.
- Interpret complex scientific and technical data to produce clear, concise, and user-friendly content suitable for diverse audiences.
- Ensure all documents adhere to company standards, industry best practices, and regulatory guidelines (e.g., FDA, EMA, ICH, cGMP).
- Participate in document review cycles, incorporate stakeholder feedback, and manage document version control.
- Support the preparation and maintenance of standard operating procedures and work instructions for manufacturing teams.
- Assist in the creation of documentation for process validations, equipment qualifications, and change controls.
- Maintain up-to-date knowledge of industry trends, regulatory changes, and technological advancements affecting pharmaceutical documentation.
- Additional requirements as assigned.
Requirements - Bachelor’s degree related to engineering/life sciences discipline.
- Proven experience (2+ years) in technical writing and operations, within pharmaceutical, biotechnology, or regulated manufacturing environments.
- Proven experience developing accurate, concise, and compliant technical documentation including SOPs and routine procedures in the pharmaceutical and engineering industries.
- Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
- Exceptional written and verbal communication skills with acute attention to detail.
- Quality and compliance driven.
- Ability to translate complex scientific concepts into clear, practical instructions.
- Proficiency with documentation management systems and MS Office Suite; familiarity with electronic document management systems (EDMS) is an asset.
- Demonstrated ability to work effectively in cross-functional teams.
- Excellent organizational and project management skills; ability to manage multiple assignments simultaneously.
- Travel is 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.
Estimated annual salary (dependent on experience) $70,000 - $73,000.
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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