Automation Technical Writer

Responsibilities:

• Collaborate closely with the controls and automation team supporting GMP biologics to deliver comprehensive documentation, encompassing both SDLC and non-SDLC needs.
• Assist in drafting, editing, reviewing, and approving documentation within the system development lifecycle (SDLC), including Quality Assurance Plans (QAP), Requirement/Configuration Specifications (RSCS), and Quality Assurance Summary Plans (QASR).
• Support system upgrades, configuration changes, and data integrity remediation efforts led by engineering, ensuring documentation alignment.
• Work in tandem with quality engineering to integrate requirements testing into protocols effectively.
• Develop and approve Standard Operating Procedures (SOPs) to streamline process development and equipment qualification within the facility.
• Extend support to other documentation initiatives, such as SOP writing, to meet organizational needs.

The ideal candidate has this preferred experience currently:

• 1 year of previous experience from a GxP facility, particularly in conducting clinical drug safety assessment testing in in vivo test models, including sample collection, processing, and basic analysis.
• Experience developing, revising, and implementing training documentation, including SOPs, job aids, and process changes.
• Experience training new technicians and coordinating with vendors.
• GxP (GMP, GLP) data review and quality control standards.

Skills and Experience:

• Possess a bachelor's degree in science or engineering.
• Exhibit a strong grasp of GxP (GMP, GLP) documentation, with hands-on experience in SOP authoring.
• Preferred experience in computer and/or automation systems, including Microsoft Windows Server, Active Directory, networking, Secure Desktop, Open Lab, Acronis, PI, Unicorn, Rockwell Ignition PLC, and Emerson DeltaV.
• Proficient in Microsoft Office suite.
• Showcased skills in project implementation, ensuring timely and effective execution.
• Basic understanding of GxP regulations and operations, with a focus on compliance.
• Demonstrate exceptional technical writing abilities, ensuring clarity and precision in documentation.
• Communicate effectively across teams and stakeholders.
• Possess a background in laboratory experience and techniques.
• Accumulation of at least 1 year of experience in SDLC processes.

Apply today!