Technical Writer

Duration: 12 Months+

Purpose & Scope:

As a member AIRM’s Manufacturing (MFG) team, the Associate I/II will be responsible for writing, revising, reviewing technical documents such as Standard Operating Procedures and Batch Records. This role is critical in ensuring the success for manufacturing campaigns by providing quality documentation to the operators to execute processes. The successful candidate will have effective writing skills, ability to capture the details and strong verbal communication skills.

Essential Job Responsibilities:

• Author new Standard Operating Procedures (SOPs) and Batch Records (BRs).
• Revise existing SOPs and BRs.
• Collaborate with Subject Matter Experts (SMEs) to capture the details accurately in SOPs and BRs and Quality Assurance (QA) to meet cGMP compliances.
• Closely work with MFG Bioprocess Leaders to draft SOPs and BRs and implement process improvement.
• Work with cross-functional teams on the implementation of processes in SOPs and BRs.
• Work effectively under tight timelines and flexible to adapt on priority changes.
• Work on any assigned tasks

Organizational Context:

• Directly reports to the sr. Manager of Cell Manufacturing.

Education:

• Associate degree with 4-6 years
• Bachelors (Science or Engineering) with 2-3 years
• Masters/PhD with 0-2 years

Experience (Required):

• Experience in writing technical documents for manufacturing operations especially for Bioprocessing equipment such as Single-Use small scale cell culture bioreactor, UFMini Single-Use centrifuge and other equipment
• Detail oriented with good organizational skills
• Able to manage priorities and maintain timelines for completion of the assigned tasks
• Detail oriented with good organizational skills
• Able to work effectively and independently, as well as part of team

Preferred

• Experience in Manufacturing, Engineering and/or Quality environment (pharmaceutical or medical device industry preferred)
• Experienced in Drug Substance (Cell Culture) and Drug Product operations.
• Strong oral, written communication, and interpersonal skills
• Critical thinking capabilities
• Experience in quality management systems for Deviations, Change Controls, BRs and SOPs
• Experience in working on Quality Document Management Systems highly preferred.

Shift: Day