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.
Qualifications
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.
Knowledge, Skills, and Abilities
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 manuals.
Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.
Ability to effectively present information and respond to questions from groups of managers and clients.
Basic knowledge of computers and Microsoft Office software products.
Applies job skills, company policies and SOPs to complete a variety of tasks.
Receives general instructions on routine work, detailed instructions on new projects or assignments.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.
