Benefits: All Silgan Unicep employees are eligible to participate in our 401k, dental, medical and/or vision benefits after a probationary waiting period.
Essential Responsibilities
- Design and draft calibration protocols for equipment.
- Execute calibration documents.
- Work effectively within a manufacturing environment as both an individual contributor and team member.
- Implement FDA/ISO documentation for equipment and/or processes including SOPs and preventive maintenance documents and forms as applicable.
- Work to ensure that calibrations are fully integrated to demonstrate that equipment consistently functions as intended to maintain regulatory compliance for the facility.
- Support Engineering and Validation personnel.
- Assist with writing Standard Operating Procedures (SOPs), Preventive Maintenance procedures, and other documents for equipment and processes as needed.
- Consult with other departments on FDA/ISO regulatory compliance as requested.
- Perform initial reviews of equipment usage to determine if systems need to be re-validated or calibrated.
- Travel between sites to provide Validation Support as needed.
- Evaluate external calibration protocols and schedule external vendors for maintaining calibration needs of the organization
- Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
- Effectively coordinate with Validation personnel to ensure that equipment and process validations are completed on time and meet the needs of the facility.
- Adhere to company safety requirements.
- Regular attendance.
- All other responsibilities as required.
Minimum Requirements
- Bachelor’s degree in Science, Engineering, or a related field, or an equivalent combination of education and experience.
- Minimum one year’s experience in calibration.
- Knowledge of ISO and FDA requirements for GMP/GLP practices.
- Experience working in a FDA regulated manufacturing facility.
- Ability to work independently with minimal direction.
- Ability to prioritize workload to meet established deadlines.
- Familiar with Chemistry, Microbiology, and Engineering terminology.
- Ability to perform basic statistical calculations and analysis.
- Experience creating and maintaining documentation and reporting.
- Proficient in Microsoft Office.
- External qualification to a recognized certifying organization for calibrations is a plus, but is not required.
PHYSICAL REQUIREMENTS:
- Regularly required to talk and hear.
- Required to sit for 3-4 hours at a time.
- Frequently required to walk and stand.
- Occasionally lift up to 25 pounds.
- Fine motor control to grasp small objects.
- Vision includes close vision, color vision and the ability to adjust focus.