Operations Process Engineer II [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Discover Impactful Work:

The Operations Process Engineer II is a critical member of the Operations Team. The Operations Process Engineer II’s primary responsibilities are: 1) developing robust and compliant procedures for Operations, 2) executing corrective actions for process failures, and 3) driving continuous improvements to address gaps in process. Operations Process Engineers are Subject Matter Experts (SMEs) of Oral Solid Dose manufacturing and are key support personnel for Operations troubleshooting and problem solving.

The Operations Process Engineer team’s current focus is on driving quality improvements to achieve department right first time (RFT) and quality compliance goals. Operations Process Engineers also assists in leading department quality investigations to resolve the root cause and identify both corrective & preventative actions for top quality losses.

A Day in the Life:

• Proactively leads process improvements for Operations department
• Participates in quality incident response, including initial response and containment, and utilizes Practical Problem Solving tools and principles to aid in root cause analysis and identification of corrective actions.
• Facilitate discussions between cross-functional teams (Quality, Tech Services, Engineering, etc.) in order to drive alignment on quality incident root cause and correction actions.
• Aid in investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Performs final functional area approval for operations owned deviation investigation reports to ensure report accuracy and alignment on root cause and correction action(s).
• Support resolution of department critical corrections / facilitate alignment on process comments and batch records notes per cGDP.
• When appropriate, revise and maintain manufacturing procedures and forms to ensure GMP compliance.
• Support Manufacturing systems to proactively identify and address quality risks, including Daily Gemba process and Quality Suggestion Program.
• Track and analyze Quality metric data for Manufacturing department to drive RFT initiatives
• Participates in inspection readiness activities in Manufacturing Areas
• Author digital forms for executing setup/run/clean batch activity in Digital Logbook system

Keys to Success:

• Bachelor’s Degree in Engineering or Science related field is required
• Minimum 2 years experience in continuous improvement, Operations SME, and/or Technical SME
• Quality, process and manufacturing investigation and technical writing experience is preferred
• Background in cGMP’s requirements is preferred
• Lean Six Sigma problem solving skills is preferred
• Experienced in Microsoft Office Word, Excel and PowerPoin t
• Ability to learn and navigate through investigation, quality and ERP systems
• Have flexibility to work various shifts times if needed to complete work content.
• Proficiency with English Language
• Equivalent combinations of education, training, and meaningful work experience may be considered
• Models effective and constructive communication and interactions with technical departments both orally and in writing.
• Maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
• Requires a passion for problem solving, attention to detail, good interpersonal skills, a sound understanding of cGMPs and Manufacturing/ Packaging.
• Ability to interact with the operations personnel, QA GMP Services, Manufacturing Engineers, Records/Release, Quality Control, QA Regulatory, Engineering.
• Autonomously prioritizes daily tasks with little to no oversight and shows attention to detail

Excellent Benefits

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided

• Must be legally authorized to work in the United States now or in the future, without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening