Location: Clayton NC

Shift: Day shift

Utilities Engineer II:

The Engineer II may supervise small shift or off shift. Participates in complex projects requiring close supervision. Understands business context of assignments and begins to develop marketing, business, negotiation and customer service skills. Provides routine technical support with limited responsibility and accountability.

The role belongs to the Utilities Operations department and is focused on supporting provision of water for pharmaceutical use, steam, Ethanol, and pressurized air to manufacturing areas.

Primary responsibilities for role:

• Makes decisions independently, but within a well-defined area.

• Builds technical expertise continuously.

• Responsible for providing engineering project support related to the design and implementation of both new and upgraded facilities, systems and equipment used in manufacturing as well as those systems that support those operations.

• Responsible for troubleshooting, continuous improvement, incident investigation and CAPA execution, system administration, data requests and reporting.

Additional Responsibilities:

• Excellent interpersonal, technical writing and communication skills.

• Strong technical and problem-solving skills in a manufacturing environment.

• Designs and operates manufacturing technology for the organization.

• Supervises quality control and oversees the fulfillment of FDA regulations.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Requirements

Education and Experience:

• Minimum Education: Bachelor’s Degree in Engineering or related field

• Minimum of 2 years of experience working in a Biotech or Chemical company.

• GMP experience preferred

Knowledge, Skills, and Abilities:

• Able to work with internal and external contacts in a technical role and operate well at a detail level with them.

• Exercise defined degree of discretion.

• Able to participate with outside associations and/or regulatory groups within established guidelines. Ability to satisfactorily handle conflict situations.

Utilities Engineer III:

The Engineer III demonstrates consistent application of technical knowledge and/or regulatory knowledge in all/some of the following Engineering disciplines; Mechanical, Electrical, Chemical, Facilities and Process. Executes assignments of medium complexity, developing solutions for defined problems. Trains others at the entry level.

The role belongs to the Utilities Operations department and is focused on supporting provision of water for pharmaceutical use, steam, Ethanol, and pressurized air to manufacturing areas.

Primary responsibilities for role:

• Sought for counsel within field of expertise for all/some of the following areas of Engineering: Mechanical, Electrical, Chemical, Facilities and Process, depending on the department.

• Makes decisions with designated assignments that influence the goals of the department.

• Produces anticipated results that contribute to business or technical goals.

• Develops alternative solutions to problems, handles complex problems independently.

• Responsible for providing engineering project support related to the design and implementation of both new and upgraded facilities, systems and equipment used in manufacturing as well as those systems that support those operations.

• Sustain facilities compliant with the FDA's Good Manufacturing Practice Regulations, as well ensure environmental and personal safety.

• Works in one or more areas of Engineering in a Manufacturing environment: Project, Plant & Reliability, and/or Utilities.

• Collaborates with other functional areas in Engineering, Manufacturing, Quality, Regulatory, etc.

Additional Responsibilities:

• Excellent interpersonal, technical writing and communication skills.

• Strong technical and problem-solving skills in a manufacturing environment.

• Designs and operates manufacturing technology for the organization.

• Supervises quality control and oversees the fulfillment of FDA regulations.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Requirements

Education and Experience:

• Minimum Education: Bachelor’s Degree in Engineering or related field; professional certifications and licenses as appropriate.

• At least 4 years of experience

• Biotech or Chemical industry experience preferred

Knowledge, Skills, and Abilities:

• Demonstrates strong technical and/or regulatory expertise and ability to adapt to changing circumstances.

• Displays flexibility with assignments in different units/plants.

• Completes assignments in more than one business unit or functional area.

• Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

• Able to lead teams and promote team approach.

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.

EEO Minorities/Women/Disabled/Veterans

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

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