Associate Process Development Engineer

About the role

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.

Responsibilities

• Supports Technical Transfer/Process Development projects including creating and maintaining product assembly instructions, ensuring product and process quality, and conducting risk assessments.
• Validates and implements new or transferred manufacturing equipment, computer system/software validations.
• Conducts risk assessments on process steps and their ability to meet requirements.
• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Supports validation projects within the cGMP regulated manufacturing areas, preparing, reviewing, and executing commissioning, qualification, and validation documents for equipment and computerized systems/software.
• Supports Project teams in User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
• Handles multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
• Designs and executes engineering (pre-validation) studies to support validation activities.
• Assists in troubleshooting of equipment/computer system issues, process characterization, and root cause investigations.
• Resolves deviations/non-conformances observed during execution of qualification and validation activities.
• Prepares/issues change controls, CAPAs, and investigations.
• Applies FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
• Safely performs duties following NACS quality standards.
• Participates in team building, training, and department communications.
• Works as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.

Qualifications

• Minimum of Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline.
• 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 decisions 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.

Education and Experience

• Bachelor's 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.