Specialist Technical Writing

Pay range: 26-36/hr
*depending on experience

Role Summary:

Acts as the primary operations contact, overseeing manufacturing process design, documentation, and compliance. Serves as SME for technical content, managing risk assessments, change controls, and regulatory requirements. Collaborates with cross-functional teams and Capital Project stakeholders to ensure timely execution of automated packaging lines.

Description:
• Primary point of contact to support operations and the organization through planning, designing, creating manufacturing processes.
• Serve as the Subject Matter Expert (SME) for documentation, specifically responsible for initiating, revising, and/or approving technical content and manufacturing procedures (SOPs, WIs, Risk Assessments, Vendor URS, Protocols & Reports) to ensure all procedures reflect equipment design, regulatory requirements, and quality standards.
• Collaborate with the Capital Project team to develop and align on the project schedule and budget, managing the work plan, risks, and overall execution throughout the project lifecycle
• Provide impact and risk assessments for Change Control Review Board (CCRB) records as the change control owner. Contribute to equipment quality risk assessments (QRAES) and ensure proper manufacturing design and controls are in place.
• Collaborate with key cross-functional teams including, but not limited to, Engineering, Quality, Supply Chain, Product Development, Tech Transfer and NPI, and External equipment suppliers to ensure timely and accurate delivery of automated, high speed packaging manufacturing lines.
• Support the development of training materials for packaging procedures and equipment operations to ensure readiness for the packaging process.
• Actively participate in workshops pertaining to technology transfer/NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Manufacturing SME and point of contact to participate in regulatory inspections/audits.