Technical Operations Specialist

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

The Technical Operations Specialist supports cGMP manufacturing by providing technical oversight, troubleshooting production issues, and ensuring reliable support for both commercial and clinical operations. The Tech Ops Specialist is responsible for preparing, executing, and evaluating Continued Process Verification activities to maintain process performance and product quality. Working closely with Technical Services, Operations, Quality, Engineering, and EHS, the specialist helps drive cross-functional alignment and resolve manufacturing challenges.

The position also manages the routing and tracking of critical documentation to ensure timely review and approval across departments. Additionally, the Technical Operations Specialist demonstrates leadership through training, mentoring, and supporting the development of team members.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Manufacturing & Process Support

• Support commercial and clinical cGMP manufacturing operations using data analysis to identify areas of improvement and overall manufacturing trends.
• Troubleshoot unexpected manufacturing events and production issues as a process SME, authoring investigations and facilitating the closure of investigations in a timely fashion.
• Ensure robust, reliable, and compliant product manufacturing.

Process Verification & Technical Oversight

• Prepare, execute, and evaluate Continued Process Verification (CPV) activities.
• Monitor process performance and identify opportunities for improvement.
• Provide ongoing technical support to manufacturing teams.

Cross-Functional Collaboration & Coordination

• Partner with Technical Services, Operations, Quality, Engineering, and EHS Teams to resolve documentation and manufacturing process issues resulting in CAPAs and process deviations.
• Coordinate activities to ensure alignment across manufacturing functions.
• Facilitate communication and issue resolution between departments.

Documentation Management & Training

• Track and route documentation through required reviewers and approval channels, ensuring timely completion of document review and information accuracy.
• Create and maintain standard work documents including checklists, MBRs, and MPR templates.
• Author Change Controls to support investigations, process changes, and equipment modifications.
• Review and approve new batch records as well as perform review of executed batch records.
• Provides training to manufacturing staff on operating procedures, batch records, and cGMP processes.

• At least 5 years of experience in a pharmaceutical cGMP Manufacturing setting is required for consideration.
• Related bachelor's degree preferred.
• Must have at least 1 year of experience in Technical Writing (deviations, SOPs, Batch Records, etc.).
• Must have demonstrated leadership and training experience.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) preferred.

• Ability to drive manufacturing operations and identify/improve inefficiencies.
• Ability to work with people at all levels of the organization.
• Ability to create and interpret graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to write reports, business correspondence and procedure…