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Hologic Sr Manager, Manufacturing Engineering in San Diego, California

The San Diego Campus is the center of our Diagnostics Solutions Division. With the focus on Molecular Diagnostics, most 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 provides unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements.

Position Summary

The Sr. Manager - Manufacturing Engineering candidate will be an essential team member managing manufacturing project engineering and associated equipment development. Areas of accountability include supporting development, purchasing, commissioning and qualification of all manufacturing production equipment and related processes. Projects start at design concept and end with production acceptance. This includes but is not limited to vendor and contract management, budgeting, core team involvement, requirement development, project planning, operational training, capacity development, cost savings, support of new equipment qualifications and product process improvements, employee training, development and performance management.

Duties and Responsibilities

  • Provides leadership for manufacturing engineering and support for all project development, including capitol equipment.

  • Management of projects, timelines, and requirements to support manufacturing engineering and operations.

  • Direct involvement with core teams driving project deliverables from implementation through completion.

  • Provides input for process development and implementation across multiple manufacturing technologies.

  • Supports process transfers from engineering to manufacturing including processes and equipment training.

  • Provides project management guidance for multiple fast-paced qualifications with varying scope.

  • Provides and manages technical engineering and mechanical support for procuring, developing, acquiring, qualifying, and commissioning equipment.

  • Manages, creates and/or modifies equipment maintenance procedures, SOP’s, and requirements.

  • Support writing and reviewing operating procedures, documents, and reports.

  • Collaborates on equipment performance testing to support new product testing and equipment qualifications.

  • Provides QS validation input and drives new equipment and product validations.

  • Exercises judgement within defined procedures and policies to determine appropriate actions.

  • Reviews and approves project plans, engineering studies and qualification documentation.

  • Establishes and ensures adherence to project budgets, work plans and performance requirements.

  • Establishes and maintains department budgets, capital and department expenses.

  • Reviews and provides guidance associated to process and equipment capability.

  • Ensures and models compliance with established business policies and ensures all applicable safety, quality and regulatory regulations are followed by manufacturing personnel.

  • Ensures completion of all employee training required engineering and maintenance methods including cGMP guidelines, and SOP’s.

  • Drafts, reviews, revises, and executes SOPs, technical reports, nonconformance’s, investigations etc.

  • Analyzes data, results, and provides conclusions and performance metrics.

  • Actively lead and support process improvement and cost saving initiatives.

  • Demonstrates commitment to the development, implementation and effectiveness of Hologic's Quality Management System per ISO, FDA, and other regulatory agencies.

Specific Development Requirements and Accountability:

  • Maintains GMP compliance

  • Capital Project Management Experience

  • Implementation of Operational Excellence

  • Improvement:

  • Implement LEAN processes

  • Implement

  • Equipment Implementation

  • MyCI (continuous improvement) Implementation /Support

  • General:

  • Combined Tier Structure

  • Cross Training and Skill Set Diversity

  • Succession Planning

  • Employee Technical Training

  • Employee Performance and Development

Qualifications

  • Experience with cGMP, manufacturing, and equipment support.

  • Working knowledge of safety regulations, federal regulations, and other regulations, e.g. QSR’s, ISO, ISO 13485, etc. in a laboratory environment.

  • Experience with automated and semi-automated equipment and processes.

  • Detail oriented with strong verbal and written communication skills.

  • Demonstrated ability to follow detailed directions in a manufacturing and engineering cGMP environment.

  • Demonstrated ability to drive project from initiation to completion.

  • Demonstrated ability to communicate a vision and provide guidance in decision making.

  • Understanding of manufacturing systems, processes, and equipment (documentation, compliance, Safety, change control, time and attendance, etc.).

  • Solid understanding of the product and manufacturing processes.

  • Strong equipment design skills.

  • Strong computer skills.

Education

  • BS/BA or equivalent work knowledge and experience

Experience

  • 6 -12 years industry experience within a cGMP environment

Specialized Knowledge

  • Knowledge of diagnostic reagent filling, packaging equipment, mixing, media storage, lyophilization, and purified water

  • Knowledge and Experience of equipment and process validation

  • Knowledge of CGMPs, ISO 13485 and FDA 21 CFR 820

  • Working knowledge of Windows based programs

  • Knowledge of PLC’s, hydraulics, pneumatics, electrical, mechanical, automation equipment maintenance and repair.

  • Knowledge MS Office and MS Project

  • PMP Certification preferred but not required

Travel

  • Approximately 0-4 times annually

Additional Details

  • Sit; use hands to finger, handle or feel objects, tools, or controls.

  • Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

  • Lifting/moving and carrying products weighing up to 40 pounds.

  • Exposure to moving mechanical parts, vibration, and/or moderate noise levels.

  • Exposure to hazardous chemicals or other materials.

Manufacturing Engineering Department Overview

The Engineering Department is comprised of three separate functional areas: Sustaining Engineering & Maintenance, Consumables Engineering and Manufacturing Engineering. The Engineering Department reports into Operations but is highly collaborative with Supply Chain, Manufacturing, R&D, PMO, and various Quality Departments.

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.

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