Hologic Operations Process Engineer-Scientist 2-3 in San Diego, California

Operations Process Engineer-Scientist 2-3

Post Date Jun 07, 2018

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.

Job Summary

The Operations Process Engineer/Scientist 3 supports various areas of manufacturing including production and testing using technical knowledge for resolution of issues or improvements related to product or processes.

Duties & Responsibilities:

  • 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

  • Responsible for developing robust analytical methods for raw materials and final product.

  • Provide technical and trouble-shooting support for analytical instrumentation and all analytical development activities.

  • 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 engineering studies, protocols, reports and test plans. Generates data summaries with complex statistical analysis.

  • Support qualification of new raw materials and supplier changes for chemicals, biologicals and solid supports.

  • 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.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.

  • Demonstrate strong understanding of chemistry/biochemistry. ELISA and Lateral Flow Immunoassay experience is a plus.

  • Demonstrates knowledge of and has the ability to perform protein purifications and conjugations.

  • 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

  • Demonstrates knowledge of and has the ability to apply stability regulations.

  • 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.