Equipment Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title : Equipment Engineer (Equipment Commissioning and Qualification) / Validation Engineer

Location : Warren, NJ

Duration : 12 + Months

Job Description

Position Overview:

The ECQ Equipment Engineer supports the successful operation of facility, laboratory and business functions at their home site through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility, and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent will be involved with writing deviations, investigations and supporting the implementation of change controls.

Essential Functions:

Operational Activities

Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas.

Supervises vendors for Calibration, preventative maintenance, and qualification functions.

Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to Celgene standards.

Works closely with, and enters data into the site CMMS system.

Ensures all calibration, PM, and qualification records are filed appropriately after approval.

Writes and supports deviations and investigations that result from qualification 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 requalification of equipment.

Support the development, review and approval of calibration and maintenance plans in site CMMS system.

Addresses BEMS equipment alarms and ensures storage equipment maintains the appropriate set points.

Supports the execution of equipment qualifications and process improvement studies.

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.

Promotes and provides excellent customer service and support

Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.

Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure 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.

Inventory Management

Work with planning group to ensure CMMS system is updated as calibration, maintenance and requalification activities are performed.

Regulatory Responsibilities

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 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.

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 inventory management systems (CMMS), mainly Blue Mountain RAM.

Ability to interact effectively with laboratory, QA, and Facilities groups.

Competencies:

Professional Knowledge

Problem Solving

Team Player / Building Relationships

Multi‐tasking

Customer Focus

Action and detail oriented

Active Listening

Education & Experience:

BS in Engineering or Science related discipline preferred.

Minimum FIVE years of experience in FDA-regulated industry preferred.

Instrumentation background and experience in laboratory and manufacturing operations.

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

Minimum 2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.

Experience working in a commercial environment preferred.

Experience writing and supporting deviations and investigations preferred.