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Responsible for functioning as an individual contributor and subject matter expert for manufacturing processes, testing, and troubleshooting. Provide engineering expertise in a technical subject matter expert capacity supporting the design and operation of equipment and systems. Actively engaged in the installation, evaluation, startup, verification, maintenance, sustainability, and process optimization of manufacturing systems and equipment. Demonstrate expertise within the engineering field while working across a variety of functional groups that are directly involved in site operations.
Responsibilities: Essential Duties
- Develops, evaluates, and improves industrial manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
- Analyzes and plans workforce utilization, space requirements, workflow, designs layout of equipment and workspace for maximum efficiency.
- Estimates production times, staffing requirements, and related costs to provide information for management decisions.
- Communicates manufacturing capabilities, production schedules, or other information to facilitate production processes.
- Confers with vendors in order to determine specifications of products and arrange equipment, material purchase, and parts.
- Evaluates products based on specifications and quality standards.
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
- It shall be the duty of every employee while at work to take reasonable care for the safety and health of himself/herself and other persons.
- Manufacturing experience (hands-on); pharma/med device or other regulated industry preferred, but not required
- Equipment troubleshooting, process improvement, project management, writing equipment procedures, developing equipment specs
- Process Validation/Qualification execution experience
- Factory Acceptance Test (FAT)
- Site Acceptance Testing (SAT)
- Installation Qualification (IQ)
- Operational Qualification (QQ)
- Performance Qualification (PQ)
- Risk Management Tools
- Root Cause Analysis
- Design FMEA (DFMEA)
Expertise: Knowledge & Skills
- Requires full working knowledge of relevant business practices and procedures in the professional field.
- Uses standard theories, principles, and concepts and integrates them to propose a course of action.
- Work under minimal supervision.
- Relies on experience and judgment to plan and accomplish assigned goals.
- May periodically assist in orienting, training, assigning, and checking the work of lower-level employees.
- Referring only to complex problems and issues
Expertise: Qualifications - Experience/Training/Education/Etc
- Bachelor's degree required or equivalent combination of education and experience.
- 6-8 years related experience required.
- Master's degree preferred.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
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.
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 moderate.