Process Engineer II

Date: Jun 24, 2022

Location: US-NY-Rochester, New York, US

Company: Bausch & Lomb

Position summary:

This lab-focused position will perform technical and supporting activities for medical device product manufacture in the Solutions Process Development Laboratory.  The person will be a technical contributor to the research and development of sterile contact lens and ophthalmic products.

 

Key responsibilities:

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

Provides support and guidance for compounding, filling, packaging and labeling of sterile and/or non-sterile product (Test, Development, Stability or Clinical).

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. Includes oversight through closure phase for activities.

Monitors, trends and reviews Environmental Monitoring and/or Hot Purified Water data to assess and verify state of control.

Generates or revises documentation pertinent to department activities. May includes technical support for making documentation and/ or process changes. Provides review of completed documentation, as part of formal review process.

Coordinates and oversees scheduling of routine maintenance of department utilities (Clean Stearn, Comnressed Air and/ or Hot Purified Water) or equipment. Coordinates and oversees calibration of department instruments and equipment. Includes oversight for completion of activities.

Represents department on project teams. Performs associated action items. Is a technical resource and specialized role in providing expertise and guidance.

Provides 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.

 

Qualifications/experience:

Bachelor's degree or the equivalent through specialized training with a minimum of 3 years of relevant experience or M.S. with 2 years of relevant ex erience, PhD/OD/MD 0-2 ears relevant experience.

Minimum of 3 years of experience working in a GMP laboratory / facility environment. Knowledge of general GMPs, as well as good documentation practices.

Applies technical understanding to problems, ideas or projects. Strong understanding in one or more technical areas.

Good organization skills, attention to detail and ability to multitask. Strong verbal and written communication skills.