Technical Writer - Manufacturing

eGenesis • Northwest Township, IN

21h • Onsite

About The Position

The Technical Writer - Manufacturing is responsible for performing site Non-Conformance Report (NCR), Significant SNCRs investigations, authoring CAPAs, standard operating procedures (SOPs), Clinical Batch Records, and miscellaneous technical transfer documentation as needed. This role will also play a critical role supporting training for operators. The candidate will execute these investigative tasks utilizing tools, identifying the root cause(s), documenting the results and processing the relevant records, collaborating with impacted departments to determine appropriate corrective or preventive actions, related effectiveness criteria. Functioning in an interdepartmental capacity, this individual will author Batch records and technical documentation alongside Manufacturing and Technical Transfer personnel. Personnel filling this role will be supporting the Development and Pre-Commercial Services (DPCS) group across eGenesis GMP facilities. The initial scope of role will be to perform duties as described with the opportunity to build a scalable organization of direct reports in the future.

Requirements

• BS in Biology, Mechanical, Electrical, Chemical Engineering or a related field
• 5+ years of experience in a GMP-regulated biotechnology, cell therapy, gene therapy, or pharmaceutical manufacturing environment
• Strong working knowledge of GMP regulations, including FDA, EMA, EU Annex 1, and relevant ICH guidelines
• Proven experience authoring and managing GMP documentation, including batch records (MBRs/EBRs), SOPs, work instructions, deviations, investigations, and CAPAs
• Demonstrated experience leading or authoring investigations, including root cause analysis, CAPA development, and effectiveness checks
• Hands-on experience supporting manufacturing operations and working cross-functionally with Manufacturing, MSAT, Process Development, and Quality teams
• Strong ability to translate manufacturing processes and technical information into clear, compliant documentation
• Experience supporting regulatory inspections, audit responses, and inspection readiness activities
• Strong written communication, organizational, and stakeholder management skills
• Ability to manage multiple documentation and investigation projects in a fast-paced, GMP manufacturing environment
• Ability to work onsite in Northwest, IN and support cross-site activities as needed

Nice To Haves

• Experience with electronic QMS and/or eBR systems (e.g., Veeva, TrackWise, Qualio, etc.) is a plus
• Experience in cell therapy, gene therapy, or biologics manufacturing is preferred

Responsibilities

• Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation
• Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams
• Provide relevant experience for training manufacturing and technical personnel both directly and indirectly
• Establish a scalable framework and organization for execution of technical and quality documentation
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
• Identify cross-functional team members and assemble the investigation/authoring teams
• Confirm corrections/containment identified based on the investigation results
• Determine the appropriate data sources to be evaluated for the investigation and obtain the required data
• Investigate the root cause(s) of the issue and document the investigation results
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan
• Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)
• Manage multiple investigations at any given time
• Responsible for speaking to clients and regulatory authorities to explain investigations
• Provide strategic oversight for facilities and equipment lifecycle management, control strategies, and inspection readiness
• Ensure all facility activities align with cGMPs, engineering best practices, and product quality requirements
• Support harmonization of global facility quality standards and training across the eGenesis network
• Lead or contribute to investigations related to facility deviations and CAPAs, including root cause and remediation
• Partner with Quality & Manufacturing teams to support regulatory submissions, inspections, and closure of observations

Benefits

• Medical insurance (80% company paid)
• Dental insurance (80% company paid)
• Vision insurance (100% company paid)
• 401k with a company match
• Paid time off and paid sick time
• Paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees