Benefits: All Silgan Unicep employees are eligible to participate in our dental, medical and/or vision benefits after a probationary waiting period.
- Establish department work priorities.
- Supervise and offer leadership to employees in accordance with policies and guidelines.
- Interview, hire, and train employees, plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints, and resolve problems as needed.
- Design, draft, and review validation protocols for processes, production equipment, and facilities equipment.
- Design and draft calibration protocols and schedules for equipment and manage the calibration program.
- Execute validation and calibration activities.
- Implement FDA/ISO documentation for equipment and/or processes including SOPs and preventive maintenance documents and forms.
- Work to ensure that calibrations are fully integrated to demonstrate that equipment consistently functions as intended to maintain regulatory compliance for the facility.
- Perform, supervise, and review documented experiments to demonstrate that equipment and processes consistently function as intended to maintain regulatory compliance of the facility.
- Write and review draft reports based on data gathered during execution of validation documents.
- Write and maintain 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 reviews of equipment usage to determine if systems need to be re-validated or calibrated.
- Travel between sites to provide Validation and Calibration support as needed.
- Evaluate external calibration protocols and supervise the scheduling of external vendors for maintaining calibration needs of the organization.
- Evaluate external validation protocols.
- Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
- Adhere to company safety requirements.
- Regular attendance.
- All other responsibilities as required.
- Bachelor’s degree in science, Engineering, or a related field, or an equivalent combination of education and experience.
- Three years’ experience in Validation in an FDA-regulated production operation.
- One year’s experience in Calibration in an FDA-regulated production operation.
- Previous Supervisory experience.
- Knowledge of the Scientific Method.
- Knowledge of ISO and FDA requirements for GMP/GLP practices.
- Experience working in an 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 proficient in Microsoft Office.
- External qualification to a recognized certifying organization for calibrations is preferred.
- Regularly required to talk and hear.
- Required to sit for 3-4 hours at a time.
- Frequently required to walk and stand.
- Occasionally lift to 25 pounds (12 kg).
- Fine motor control to grasp small objects.
- Vision includes close vision, color vision and the ability to adjust focus.
Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.