Technical Writer

Psc Biotech - Indianapolis, IN

Full-time - Mid Level

Indianapolis, IN

Professional, Scientific, and Technical Services

About the position

We are hiring a detail-oriented and motivated Technical Writer to join our team at PSC Biotech. In this role, you will be responsible for developing and maintaining technical documentation that is crucial for our operations in the pharmaceutical industry. This includes creating Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, as well as Standard Operating Procedures (SOPs) and Work Instructions (WIs) for various processes. Your work will involve collaborating with cross-functional teams, including engineering, quality assurance, and manufacturing, to gather necessary information and ensure that all documentation is accurate and comprehensive. As a Technical Writer, you will also identify opportunities for process improvements and contribute to the development and maintenance of documentation best practices. It is essential that all documentation complies with industry standards and regulatory requirements, including FDA, GMP, and GLP guidelines. You will be expected to manage multiple projects simultaneously and meet deadlines while maintaining a high level of attention to detail and commitment to producing error-free documentation. Given that many of our projects and clients are located in various regions around the country, 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.

Responsibilities

• Develop and maintain technical documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Create Standard Operating Procedures (SOPs) and Work Instructions (WIs) for various processes within the pharmaceutical industry.
• Collaborate with cross-functional teams, including engineering, quality assurance, and manufacturing, to gather information and ensure accurate documentation.
• Identify opportunities for process improvements and contribute to the development and maintenance of documentation best practices.
• Ensure all documentation complies with industry standards and regulatory requirements, including FDA, GMP, and GLP guidelines.

Requirements

• 3+ years of technical writing experience within the life science industry.
• Excellent technical writing and documentation skills.
• Strong knowledge of cGMP regulations.
• Strong understanding of pharmaceutical processes and regulatory requirements.
• Excellent communication skills, both verbal and written, with the ability to convey complex technical information clearly and concisely.
• Attention to detail and a commitment to producing error-free documentation.
• Highly motivated with the ability to work independently and manage multiple projects.

Benefits

• Disability insurance
• Health insurance
• Dental insurance
• 401(k)
• Tuition reimbursement
• Paid time off
• Employee assistance program
• Vision insurance
• 401(k) matching
• Life insurance
• Pet insurance