Essential Job Functions
1) Operational Activities
a. Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas.
b. Supervises vendors for Calibration, preventative maintenance, and qualification functions.
c. Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to *** standards.
d. Works closely with, and enters data into the site CMMS system.
e. Ensures all calibration, PM, and qualification records are filed appropriately after approval.
f. Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions.
g. Support the development, revision and review of written procedures for calibration, preventive maintenance and requalification of equipment.
h. Support the development, review and approval of calibration and maintenance plans in site CMMS system.
i. Addresses BEMS equipment alarms and ensures storage equipment maintains the appropriate set points.
j. Supports the execution of equipment qualifications and process improvement studies.
k. Adheres to all policies and procures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.
2) Promotes and provides excellent customer service and support
a. Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
3) Inventory Management
a. Work with planning group to ensure CMMS system is updated as calibration, maintenance and requalification activities are performed.
4) Regulatory Responsibilities
a. Maintains all required Corporate, Facilities and EHS training as required.
b. Adheres to all safety procedures and hazard communication.
c. May be called upon to act as Subject Matter Expert in both internal and regulatory audits.
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
- Ability to interact effectively with laboratory, QA, and Facilities groups.
- Experience troubleshooting Beckman Coulter Multisizer 4e
- Experience working in a sterile environment
- Professional Knowledge
- Problem Solving
- Team Player / Building Relationships
- Customer Focus
- Action and detail oriented
- Active Listening
Education & Experience:
- BS in Engineering or Science related discipline preferred.
- Minimum 5 years’ experience in GMP laboratory or manufacturing environment / regulated industry required.
- Minimum 2-3 years' experience working with and troubleshooting complex laboratory equipment required.
- Experience writing and supporting deviations and investigations preferred.
- Experience working with CMMS systems, mainly Blue Mountain RAM preferred.
Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
- Will likely spend 70% of their time in a laboratory or manufacturing environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
- Ability to work safely and effectively when working alone, or working with others.