(Archived) Manufacturing GMP Sanitization Associate, Fremont CA

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Manufacturing GMP Sanitization Associate performs and coordinates GMP cleaning and Sanitization of process areas on the manufacturing floor as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This role is responsible for cleaning, sanitization of small parts and hoses used in the manufacturing process. The incumbent performs duties under limited supervision and according to standard operating and manufacturing procedures.

Duties & Responsibilities

• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Responsible for maintaining function KPIs.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains production areas according to predefined standards (5s).
• Ensures all rooms are cleaned within assigned timelines (daily, weekly, monthly), and documented in the appropriate GMP system.
• Prepares cleaning solution applicate to the area.
• Cleans specified rooms on the manufacturing floor using approved cleaning solution, wearing appropriate PPE including respirator maybe required.
• Schedules and coordinates all daily cleaning activities and sanitization procedures.
• Performs other duties as assigned such as, trash removal, floor to ceiling cleaning, tidying up areas (5S), and potentially cleaning of small parts and equipment, performing real time documentation of cleaning in each area.
• Responsible for staying current with online training and qualifications.
• Responsible for training and mentoring junior staff on all cleaning and sanitization procedures.

Requirements

• High school diploma + minimum one (1) year work experience in cleaning of GMP regulated industry.
• Ability to concentrate on detail-oriented work in a moderate technical setup with a Quality and Right the first-time mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and ideally experience with process.
• Must become familiar with cleaning chemical components and safety requirements.
• Wear proper PPE that may include respirator to protect from cleaning agents, safety shoes, gloves.
• Must be a trainer and help train newer staff.
• Ability to Steam in place (SIP) and Clean in place (CIP) Production tanks.
• Must be able to obtain full medical respiratory clearance and successfully complete respirator fit test.
• Ability to perform repetitive motions and may require bending and reaching overhead, ability to lift to 40 lbs.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Compensation Data

This position offers a base salary typically between (44,000) and (84,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.