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 work force 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 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 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 judgement to plan and accomplish assigned goals.
- May periodically assist in orienting, training, assigning and checking the work of lower level employees.
- Referring only 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.
The client offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.