Process Engineer, Ops Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Manufacturing
This position provides direction and support to the manufacturing area utilizing industry standard problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include, but are not limited to, monitoring of current manufacturing processes, reduction of variation, control/mitigation of process drift, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc), validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing.
Deals with all technical functions (Manufacturing, Engineering, Quality, R&D, Regulatory) on a continual basis presenting technical expertise and support as needed. Works with the Manager of Manufacturing and Quality Control to address identified manufacturing problems, solutions and improvements in the manufacturing areas. Participates in cross-functional teams and may lead / support interdepartmental project team/s.
PROBLEM SOLVING/DECISION MAKING:
Candidate must be able to resolve complex technical problems independently and collaboratively in a timely manner in order to minimize production schedule disruptions. Candidate must possess ability to develop experimental plan and execute associated activities per communicated timelines. Must have a thorough understanding of manufacturing processes related to immunochemistry and lateral flow platforms.
Although this position has no direct supervisory responsibilities, this position will provide guidance to staff members within the Manufacturing and Quality Control Departments in carrying out experiments and/or project work.
Education and Experience:
BA/BS in life sciences or engineering and 5+ years experience within a cGMP manufacturing environment.
Good analytical and problem solving skills
Good knowledge of process optimization, scale up and standardization.
Good organizational skills, and the ability to manage multiple tasks
Ability to plan and execute experiments to:
- Develop new processes and set specifications
- Characterize materials and set specifications
- Troubleshoot problems
- Write and execute associated validations
Ability to work within cross-functional teams.
Good communication skills, written and verbal.
Knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.).
Demonstrates ability to consistently meet proposed objective timelines, applying competent use of project planning and project management skills
Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts)
Knowledge of related quality system regulations and processes
Appropriate computer skills (e-mail, word processing, graphing software)
Experience in lateral flow technology preferred.
Physical Demands/Working Environment:
General laboratory and office environment. Ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted. Up to 75% of time at lab bench or desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.
Quidel is proud to be an Equal Opportunity/Affirmative Action Employer (M/F/D/V).
||Athens, OH 00000 |
THIS JOB HAS EXPIRED