Job Description

Overview

The Engineer IV, Manufacturing / Process Engineering, manages and/or facilitates the design, installation, and commissioning of new equipment, facilities, utilities, computer systems, and laboratory equipment, modifications and upgrades, and troubleshooting for existing processes. Extensive knowledge of electromechanical and electronic controls (PLC’s), liquid packaging, process distillation, thermodynamics, materials handling, water system design and management, regulatory and quality control compliance.  Ensure that commissioning and qualification activities are completed satisfactorily and in a timely manner and comply with all MOH requirements.

Responsibilities

Develops project objectives by reviewing project proposals and plans; conferring with management.

Determines project schedule by studying project plan and specifications; calculating time requirements; sequencing project elements.

Maintains project schedule by monitoring project progress; coordinating activities; resolving problems.

Determines project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates.

Confirms product performance by designing and conducting tests.

Controls project plan by reviewing design, specifications, and plan and schedule changes; recommending actions.

Controls project costs by approving expenditures; administering contractor contracts.

Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.

Lead process and equipment troubleshooting to support deviations, corrective actions and related issues.

Develop and implement standard operating procedures (SOP’s) or automation improvement changes.

Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact for contractor services including design, fabrication, installation and validation.

Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules.

Conduct employee training (cGMP / OSHA/etc.) and maintain records.

Provides training for plant personnel including the design and format of commissioning and qualification protocols and the documentation of results to ensure that protocols are properly documented in accordance with cGMP's.

Oversees the commissioning and qualification process by writing, reviewing, executing, and/or approving protocols to ensure that the process is consistent, meets MOH guidelines, complies with cGMP's and meets all company policies and procedures.

Provides technical expertise in the design and implementation of commissioning and qualification protocols to ensure that validations comply with MOH guidelines and cGMP's.

Maintains and improves the validation system through establishment or changes to Standard Operating Procedures.

Support the Change Control process for all validated systems.

Works to build a team environment with all departments.

Performs other duties as assigned.