Our client, a leading pharmaceutical company, is hiring a Equipment Commissioning & Qualification (ECQ) Engineer on a contract basis.
Work Location:
Summit, NJ – 100% on-site
Summary:
Knowledge/Skills Required/Education:
- BS in Engineering or Science related discipline preferred.
- 2 years’ experience in FDA-regulated industry.
- Experience working directly with bench top manufacturing and laboratory equipment (cell counters, liquid handlers, Flow Cytometry, etc.) preferred.
- Knowledge of cGMP in the pharmaceutical industry.
- Excellent computer skills including knowledge of calibration management and environmental monitoring systems.
- Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
- Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
- 2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
- Experience working in a commercial environment preferred.
- 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 where individual initiative, accountability to the team, and professional maturity are required.
- Strong multitasking 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.
- Highly 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.
- Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.
- Ability to interact effectively with laboratory, QA and Facilities groups.
Responsibilities:
- Executes equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas.
- Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
- Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to Company standards.
- Works closely with and enters data into the site CMMS system.
- Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
- Writes and supports deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.
- Support the development, revision and review of written procedures for calibration, preventive maintenance and performance verification of equipment.
- Support the development, review and approval of calibration and maintenance plans in site CMMS system.
- Supports the execution of equipment performance verification and process improvement studies.
- Adheres to all policies and procedures which govern the ECQ team and the equipment they
- manage to ensure compliance is held to the highest standard.
- Promotes and provides excellent customer service and support.
- Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests.
- Provides technical support and guidance on calibration, equipment performance verification and validations issues. Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
- Work with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
- Maintains all required Corporate, Facilities and EHS training as required.
- Adheres to all safety procedures and hazard communication.
- May be called upon to act as SME in both internal and regulatory audits.