Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products that consistently meet or exceed customer, regulatory, and company requirements. This position will support in Technical Transfer activities, improve current manufacturing processes and supporting procedures; analyze and solve problems from basic engineering principles, theories and concepts through complex and advanced problems; and prepare and execute commissioning, qualification, and validations for new equipment and computerized systems/software.
- Participates in and supports Technical Transfer/Process Development projects including but not limited to:
- Create and maintain product assembly instructions.
- Assure product and process quality by designing testing methods, testing finished goods, determining product and process capabilities, establishing standards, and confirming manufacturing processes with guidance from management.
- Validation and implementation of new or transferred manufacturing equipment, computer system/software validations.
- Conduct risk assessment on process steps and their ability to meet requirements.
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
- Participates in and supports validation projects within the cGMP regulated manufacturing areas including but not limited to:
- Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
- Supporting Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
- Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
- Design and execute engineering (pre-validation) studies to support validation activities.
- Assisting in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
- Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
- Ability to prepare/issue change controls, CAPAs, and investigations.
- Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
- Safely perform duties following NACS quality standards.
- Participate in team building, training and department communications.
- Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.
- Maintain a commitment to NACS’s vision and “spirit” by partnering with new and current employees by demonstrating outstanding service and integrity.
- The goal of each team member - and the team as a whole - is to create effective communications that help all employees clearly understand overall company objectives and the role they play in helping NACS meet those objectives.
- Other duties may be assigned.
Minimum of Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline. To perform this job successfully, the 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.
- Ability to apply sound engineering logic to solve complex problems, assess risks, and make decision accordingly.
- Basic understanding of ISO Quality System requirements and FDA regulations.
- Problem solver able to determine root cause of technical issues and implement effective solutions in a timely manner.
- Creative thinker with ability to think ‘out of the box’ in a fast-paced entrepreneurial environment.
- Resourceful and ability to adapt to a variety of situations.
- Demonstrated ability to prioritize, initiate, and drive projects to completion.
- Solid knowledge of engineering fundamentals; ability to apply this knowledge to manufacturing and product.
- Strong attention to detail.
- Must be well organized.
- Must have proficiency with MS Office such as Word and Excel.
- Must have good written and verbal communication skills.
Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline with preferably 1-3 years of relevant experience or 5-7 years of experience without a University Degree.
Experience in Equipment Qualification and Computer System/Software Validation preferred.
Ability to read, analyze, and interpret complex documentation. The ability to write complex documentation is required. Ability to effectively communicate with all levels within the company.
Knowledge and application of mathematics, trigonometry, algebra, and statistics required.
Must be able to foresee changing project schedules and adjust personal assignments accordingly. Ability to adapt to a rapidly changing work environment and still maintain department effectiveness.
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 duties of this job, the employee is regularly required to stand, sit, talk, walk, use hands, see, and hear. Drive to customer sites for meetings. Infrequent lifting of up to 25 pounds is required.
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 environment is generally clean and the noise level is moderate. Air is generally clean with occasional welding smoke or cleaning solvent smell. Production environment will include an ISO class 7 or 8 cleanroom.
Required
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Bachelors or better in Engineering or related field
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
