Process Engineer I

Bausch+Lomb; City of Rochester (NY); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Eye Health, Life

401K with company match

Paid time off (vacation, holidays, and

Sick time

Employee stock purchase plan

Employee incentive bonus

Tuition reimbursement

Performance feedback & annual review

Job summary

Bausch+Lomb is seeking a lab/validation specialist to perform technical and supporting activities for Medical Device product manufacture in the Solutions Process Development Pilot Laboratory.

You will support validation activities, compounding and packaging operations, document control, CAPA and NCR processes, plus equipment calibration and inventory management to sustain production schedules.

Qualifications

• Knowledge of GMPs and good documentation practices.
• Experience in GMP laboratory/facility environments preferred.
• Strong organizational, multitasking and communication skills required.

Responsibilities

• Perform and/or support validation activities and document validation work.
• Support compounding, filling, packaging, and labeling of sterile/non-sterile products.
• Weigh and dispense raw materials; maintain proper documentation and systems.
• Initiate CAPAs and NCRs; follow through to closure in required systems.
• Monitor Environmental Monitoring data and Hot Purified Water data.
• Draft and review SOPs, maintenance instructions, and other docs.
• Coordinate maintenance and calibration of department equipment and utilities.
• Manage inventory and supplier sources for raw materials and supplies.
• Represent department on project teams and support ComplianceWire/ERPLx usage.

Skills

Organization

Attention to detail

Multitasking

Verbal communication

Written communication

Teamwork

Education

Bachelor's degree or equivalent

MS with relevant experience

Job description

Objectives

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

Responsibilities

• 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.

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.