Process Engineer I

Socket.dev; Rochester (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401K with company match

Paid time off

Employee Stock Purchase Plan

Tuition Reimbursement

Job summary

Bausch + Lomb is seeking candidates for roles in its Solutions Process Development Pilot Laboratory to support medical device product manufacturing. You will perform validation activities, support compounding, filling and labeling, and help maintain cleanroom and manufacturing utilities.

The role requires GMP knowledge, strong communication, and teamwork in a fast-paced environment. Minimum qualifications include a Bachelor’s or MS in a related field with relevant experience.

Qualifications

• Bachelor’s degree or MS with 0-2 years experience; specialized training for 0-3 years depending on degree.
• Experience in GMP laboratory or facility environment.
• Strong organization, multitasking, and communication skills.

Responsibilities

• Performs validation activities and maintains documentation.
• Supports compounding, filling, packaging and labeling of sterile/non-sterile products.
• Maintains Environmental Monitoring and calibration of equipment.
• Coordinates routine maintenance of utilities and equipment.
• Maintains a cgMP compliant warehouse and manages inventory.
• Trains and provides technical support at all levels.

Skills

GMP Experience

Detail-oriented

Communication

Teamwork

Documentation

Education

Bachelor’s or MS in related field

Job description

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives:

Perform technical and supporting activities for Medical Device product manufacture in the Solutions Process Development Pilot Laboratory.

Responsibilities:

Responsibilities may include:

Performs and / or supports validation activities. Creates / edits / reviews validation documentation. Coordinate and follow-up with R&D departments pertaining to required validation supplies and testing of samples.

Provides support for compounding, filling, packaging and labeling of sterile and/or non-sterile product (Test, Development, Stability or Clinical). May include cleaning and use of equipment. May include operation and sampling of facility Hot Purified Water System.

Weighing and dispensing of raw materials.

Use of appropriate documentation / systems to support assigned activities.

Initiates QCRs and/or Nonconformance/CAPAs in pertinent system(s) and continues to support record(s) through closure phase.

Monitors and trends Environmental Monitoring and/or Hot Purified Water data.

Generates or revises documentation pertinent to department activities. May include technical support for making documentation and / or process changes. Provides review of completed documentation, as part of formal review process. May include documentation creation (i.e., SOP’s and Maintenance Instructions of newly acquired equipment).

Performs, coordinates and oversees scheduling of routine and non-routine maintenance of department utilities and equipment (major and minor) i.e., Pure Steam Generator, Compressed Air, Hot Purified Water Loop, Multi-Effect Purified Water Still, filling/compounding equipment.

Coordinates and oversees calibration of department instruments and equipment.

Maintain Warehouse in cGMP compliant state.

Coordinates and oversees inventory management and handling of raw materials, components and department supplies to ensure uninterrupted production schedule; (i.e., identify new, secondary sources for critical raw materials; source and purchase new raw materials; order filters, cleanroom supplies, etc.).

Order and maintain inventory to support reference standards, lens stability, formulations development and placebo manufacture for stability testing.

Represents department on project teams. Performs associated action items.

Provides department support in the administration of ComplianceWire.

Provides department support in the administration of ERPLx.

Maintains a safe and compliant work environment by following standards, procedures, and company requirements.

Maintains on the job knowledge and skills by participating in applicable training.

Trains and provides technical support at all levels.

Requirements:

Bachelor’s degree or the equivalent through specialized training with a minimum of 0-3 years of relevant experience or M.S. with 0-2 years of relevant experience.

Experience working in a GMP laboratory / facility environment. Knowledge of general GMPs, as well as good documentation practices.

Good organization skills, attention to detail and ability to multitask. Strong verbal and written communication skills. Works effectively on teams.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $65,000.00 and $90,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Our US Benefit Programs: Employee Benefits: Bausch + Lomb

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.