Support Operational and Performance Qualifications for new products introduced to the facility.
Ensure equipment and processes meet GMP, FDA, and customer requirements.
Technical Documentation Development
Create and maintain product-specific Master Batch Records (MBRs).
Develop Master Setup Sheets and Work Instructions supporting validated processes.
Prepare Label Requests and ensure labeling accuracy and traceability.
Ensure documentation supports efficient, compliant, and validated production.
Packaging & Component Evaluation
Perform technical evaluations of packaging components and processes.
Assess and document the impact of changes to packaging and serialization processes as they relate to validation and documentation requirements.
Project Support & Collaboration
Participate in cross-functional projects related to product introductions, validation, and process changes.
Collaborate with Engineering, Quality, Operations, and Production teams.
Support training of teams on new documentation, processes, or technologies as needed.
Continuous Improvement
Identify inefficiencies in validation or documentation processes.
Propose and implement process improvements.
Support or initiate RCAs, Change Controls, CAPAs, Risk Assessments, and Validation activities in accordance with procedures.
Qualifications
At least two years of prior experience in a Pharmaceutical cGMP environment is required for consideration.
Experience in technical and/or validation writing.
Bachelor's Degree or equivalent of 5+ years prior experience in related position preferred.
Knowledge, Skills, and Abilities
Strong attention to detail and ability to follow regulatory requirements.
Excellent verbal and written communication skills.
Proficiency with Office 365 (Word, Excel) and Microsoft Teams.
Familiarity with manufacturing operations and production support.
Ability to manage multiple priorities and meet timelines in a regulated environment.
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 stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must 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 frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals 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, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
