Hologic is one of the world’s most innovative medical technology companies and a global champion of women’s health.  We advance diagnostic, detection, and surgical solutions that respond to an increasingly complex and demanding global healthcare environment.  What powers our growth is also what differentiates us: the exceptional, clinically proven ability of our products to detect, diagnose, and treat illnesses and other health conditions earlier and better.

The San Diego Campus is the center of our Diagnostics Solutions Division.  With the focus on Molecular Diagnostics, the majority of products produced from the San Diego site are utilized onboard innovative and fully automated sample-to-result instrument systems.  The consumables required for patient testing are integral to our business.  The business growth projections and new product development projects provide unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements.

Hologic is seeking a Water Systems Engineer responsible for providing engineering support services for the design, maintenance and optimization of critical water systems and the automation development, evaluation, purchase, installation, qualification improvement of new manufacturing equipment.

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. 

Provides general engineering services and support Design, develop, and implement water purification, storage, and distribution systems, including ROEDI (Reverse Osmosis Electrodeionization) DI (Deionized), Purified Water (PW), and clean steam systems, ensuring compliance with relevant regulatory standards (e.g., USP, EP).  Oversee the installation, commissioning, qualification and upgrades of current water systems and modifications to existing systems.  Develop and maintain Piping and Instrumentation Diagrams (P&IDs), system layouts, and other technical documentation for water systems.  Establish and maintain preventative maintenance programs for all water system components, including pumps, valves, filters, and instrumentation.  Troubleshoot and resolve operational issues related to water systems, including mechanical, electrical, and control system failures.  Develop implement and improve upon Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the operation, maintenance, and monitoring of water systems.  Perform routine monitoring and testing of water systems to ensure water quality specifications are consistently met.  Analyze water quality data, identify trends, and implement corrective and preventative actions (CAPAs) as needed.  Manage and coordinate with external vendors and contractors for system maintenance, repairs, and upgrades.  Ensure compliance with all safety regulations and environmental guidelines related to water systems.  Participate and provide guidance in validation activities, including protocol development, execution, and report generation.  Identify and implement improvements to water system efficiency, reliability, and cost-effectiveness.  Provide technical expertise and support to other departments regarding water system-related issues.  Maintain accurate records of system performance, maintenance activities, and deviations. Manage the design, acquisition, installation and commission of mechanical/electrical equipment, systems and parts to support manufacturing Provides technical engineering support for repairing, troubleshooting and modifying equipment and systems Manage outside vendors with establishing relationships to provide equipment proposal, user requirement specification, development, installation, qualification and sustaining support of equipment and processes Writing and reviewing operating procedures, documents, and reports Writing and reviewing Design of Experiments and other Engineering study to challenge functionality of automated equipment Performs equipment, process, and product performance testing Manage qualifying and changes in raw materials, vendors and perform investigations for non-conformance events Reviews and approves calibration, preventative maintenance, and other associated datasheets

Required Competencies

In-depth knowledge of water purification technologies, including but not limited to reverse osmosis (RO) ultrafiltration (UF), electrodeionization (EDI) and distillation Familiarity with cGMP regulations and guidelines related to water systems in the pharmaceutical or biotechnology industry. Working knowledge of microprocessor controls, utility distribution systems and process engineering Biotech / Medical Device / Pharmaceutical industry experience Thorough knowledge of manufacturing automation systems and best design practice Experience with PLC/SCADA systems used for water system control and monitoring.  Strong understanding of piping systems, pump hydraulics, and instrumentation.  Proficiency in reading and interpreting P&IDs and other engineering drawings.  Excellent problem-solving, analytical, and troubleshooting skills.  Strong technical writing and communication skills.  Ability to work independently and as part of a multidisciplinary team. High proficiency with Microsoft Suite  High proficiency with statistical analysis techniques  Working knowledge of manufacturing automation systems and design practices Working knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820 Identifies problems, solves them, acts decisively, and shows good judgment Plans and organizes work efficiently to manage time wisely.  Prioritizes tasks within a dynamic and fast-paced working environment Exhibits a high level of energy and is self-motivated to sustain ambitious work Continuously seeks new knowledge and rapidly assimilates it into the organization

Required Education and Qualifications 

BS degree in Chemical Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related Engineering discipline  Minimum 6 - 8 years of related industry experience Certified Water Technologist (CWT) preferred but not required Lean Manufacturing and/or Six-Sigma Certification preferred but not required Certified Quality Engineering Certification preferred but not required

The annualized base salary range for this role is $95,800 to $149,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

#LI-RF1 #mid-level

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.