Mechanical Engineer I/II/III - SFF

for role (level specific responsibilities should be included in the chart below) :

• 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.
• 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 / or supervisors may assign other duties as needed.

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.

Knowledge, Skills and Abilities

• Works with internal and external contacts in a technical role and operates well at a detail level with them.
• Exercises defined degree of discretion.
• Participates with outside associations and / or regulatory groups within established guidelines.
• Satisfactorily handles conflict situations.

Level II Education & Experience :

• Bachelors Degree in Engineering or related field
• Minimum of 2 years of experience working in a Biotech or Chemical company.
• GMP experience preferred.

Level III Education & Experience :

• Bachelors Degree in Engineering or related field
• Professional certifications and licenses as appropriate
• At least 4 years of experience; Biotech or Chemical industry experience preferred

Level IV Education & Experience :

• Bachelor's Degree in Engineering or related field
• Typically requires 5 years of related experience.
• Depending on the area of assignment, directly related experience or a combination of directly related education and experience and / or competencies may be considered in place of the stated requirements.

Example : If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

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.

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