Operations Process Engineer-Scientist 2 at Hologic
Posted in Sales 30+ days ago.
This job brought to you by eQuest
Location: San Diego, California
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access. None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities. While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
The Operations Process Engineer -Scientist 2 supports various areas of manufacturing including production and testing using technical knowledge for resolution of issues or improvements related to product or processes.
The Operations Process Engineer/Scientist 2 supports various areas of manufacturing including production and testing using technical knowledge for resolution of issues or improvements related to product or processes.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Become a subject matter expert (SME) on multiple manufacturing processes/ products
Perform risk assessments for process deviations and Product Response Team in support of Manufacturing
- Oversees the resolution of manufacturing process issues to ensure on-market product availability.
- Possesses skills required for communication and collaboration with internal customers to develop/modify manufacturing processes/procedures.
Prepares and executes protocols, reports and test plans. Generates data summaries with complex statistical analysis.
- Support qualification of new raw materials, container closures, resins, vendors.
- Supports the development or modification of product specifications.
- Supports regulatory affairs with technical submissions.
- Provides SME support in internal/external audits.
- Performs Design/Risk assessments for change orders.
- Participates in the development of pFMEAs.
- Demonstrate strong understanding of chemistry/biochemistry. NAT experience is a plus.
- Demonstrate knowledge of process engineering/validation
- Demonstrates strong peer to peer communication skills.
- Demonstrates knowledge of and has the ability to apply concepts of statistical analysis
Good understanding of design control and risk management.
Ability to troubleshoot and solve technical issues
Sound technical writing
- Ability to work independently with little to no supervision on increasingly complex projects.
- Knowledge of cGMP, QSR and ISO regulated environments including knowledge of compliance enforcement necessary for 510K and PMA products.
- Good understanding of root cause analysis methods
- Ability to work in and/or lead cross-functional improvement teams
Education and Experience
BS and 6 years or MS and 4 years or PhD and 0-2 years related experience in scientific discipline
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.