"Alerted.org

DESCRIPTION

Position Overview

We are seeking a skilled and dedicated Engineer to join our team. This role is essential in ensuring the smooth operation and maintenance of our facilities, including equipment. The ideal candidate in this position will oversee several departments and programs within the company including physical monitoring, metrology, and building management systems. This person will write and approve engineering documents, develop equipment calibration and preventative maintenance, use a computerized maintenance management system to submit, review, and approve documentation. In addition to technical expertise, this position requires the ability to coach direct reports, execute engineering studies, and authoring or reviewing quality reports. This candidate will conduct internal and regulatory audits for engineering topics.

Essential Duties and Responsibilities

+ Oversee metrology department and program.

+ Oversee the equipment and facility continuous monitoring and building management systems.

+ Oversee the facility physical monitoring program.

+ Collaborating with QA and QC for timely product disposition.

+ Write and approve engineering documents, including SOPs, URS, Commissioning Protocols and Reports.

+ Work with equipment owners to develop equipment calibration and preventive maintenance requirements and/or vendors.

+ Submitting, reviewing and/or approving work orders and other equipment workflows within a computerized maintenance management system.

+ Source equipment and vendors based on manufacturing and other department needs.

+ Ability to coach direct reports.

+ Execute engineering studies such as FAT, SAT and/or commissioning/de-commissioning.

+ Authoring and/or reviewing quality records such as change controls, quality events, and CAPAs.

+ Internal and regulatory audits lead for engineering related topics, including metrology, equipment monitoring, and physical monitoring.

+ Must be capable of resolving escalated issues arising from operation and requiring coordination with other departments.

Qualifications

+ 10 or more years of experience working in a GMP environment, preferably in the pharmaceutical industry.

+ B.S. in Engineering or related field preferred.

+ Must have at least 3 to 5 years of managerial experience, preferably in the pharmaceutical industry.

Physical Demands

+ Prolonged periods of working both inside and outside of the building.

+ Prolonged periods sitting at a desk and working on a computer.

+ Must be able to lift and/or move up to 20 pounds at times. Bending, stooping, crouching, and balancing may be required.

+ Must be able to access and navigate all areas of the company.

+ Must be able to access all parts of the company equipment.

Powered by JazzHR