Job Description
The Automation Manager will work to develop automation and control systems for medical radioisotope processing systems including particle accelerator based systems. The position will lead engineers in developing detailed system requirements, including documentation, development, procurement, system build, commissioning and qualification testing. This position will include management of internal resources programming PLC and HMI, as well as selection and management of outside vendors providing services to support Company’s automation requirements. This role will also lead the development and testing of Manufacturing Execution Systems (MES) and associated networking and data management systems. This individual will be required to work with cross functional teams, including RA/QA and Process Engineering to apply efficient cGMP processes to preserve data integrity and the quality of the final drug product, including the safety of all production and non-production personnel.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Develop strategy, build staff, and lead the team responsible for:
2. Ensure effective maintenance and availability of controls equipment.
3. Lead the validation of automation systems per cGMP and Regulatory guidance.
4. Participate in process risk and hazard reviews and modify equipment/designs as necessary to ensure safe operation and appropriate specifications are captured.
5. Review internal user requirements to design and implement new Automation Systems and modify existing Systems.
6. Responsible for working with OEM vendors to ensure product design, architecture and hardware conform to overall process requirements
7. Assist production and service personnel in troubleshooting automation systems. Assist in developing service manuals, procedures and maintenance related documentation.
8. Provide support to qualification and engineering personnel involved in automation FAT’s and SAT’s.
9. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
10. Support Company’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel both domestically and internationally up to 5% of the time. This role will require significant work in our Beloit Manufacturing Location which could peak to 100% of the time during system validation periods.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in Engineering, or an associated discipline, and 10 or more years of experience with a concentration in Controls Engineering, including both software and hardware; or combination of education and experience. Knowledge of hardware design and maintenance. Specific knowledge of Siemens automation products (SIMATIC), experience and working in a regulated pharmaceutical/medical device manufacturing environment is preferred.
COMPUTER SKILLS
Demonstrated proficiency of PLC and HMI programming including databases and system interfacing languages. Experience with AutoCad Electrical or comparable design software. Proficient knowledge of Microsoft Office software programs including Outlook, Word, Excel, PowerPoint and Visio.
LANGUAGE SKILLS
Ability to read and comprehend all documents including complex proposals, safety rules, operating and maintenance instructions, procedure manuals and governmental regulations. Ability to write detailed reports and correspondence on specifically assigned subject matter. Ability to speak effectively before groups of our customers, management or employees of the organization.
MATHEMATICAL SKILLS
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to solve complex relational problems with many unrelated variables.
OTHER QUALIFICATIONS
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is required to stoop/bend, squat/crouch, kneel, climb, work at/above shoulder height with both hands, use both hands/arms for strong grasp and either hand to turn or twist, and may lift/carry and/or move up to 30 pounds routinely, and 75 pounds occasionally. The employee is occasionally required to walk, stand, push and pull. The employee is frequently required to sit, and may use both hands constantly for fine manipulation or finger dexterity. The employee may be required to handle loads up to 35 pounds above shoulder height, and loads up to 75 pounds below knuckle height. Specific vision abilities required by this job include near vision/acuity and visual color discrimination. The employee is also regularly required to speak and hear.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet. The environment is a well-lit, heated, and/or air- conditioned indoor office/production setting with adequate ventilation.
Employee will work in a radiation environment and acknowledges he/she will be monitored with supplied dosimetry.
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