Senior Process Engineer - Fill Finish

JOB SUMMARY

Vibalogics is seeking a highly motivated Senior Process Engineer – Fill Finish to join our Engineering team.  This position will be responsible for equipment systems used to manufacture commercial and clinical drug product at a cGMP facility. Prior knowledge of VarioSys filling lines strongly preferred.  The individual will act as engineering lead for campaign support, deviation investigation and on floor troubleshooting. The successful candidate will be responsible for managing equipment changes in a highly regulated environment, working closely with cross functional teams and ensuring deadlines are met.  Hands-on single use manufacturing experience and exceptional communication skills are important.

REPORTING RELATIONSHIPS:  Engineering Consultants, Interns and vendor representatives, plus the future opportunity to build a small team

ESSENTIAL RESPONSIBILITIES

• Serve as technical expert for VarioSys filling line, plus other equipment used in filling operations such as FITs, SUMs, Wireless Glove Testers, etc.
• Support design and selection of process equipment to support new projects, with a focus on single use equipment.
• Support CQV readiness and assist with execution
• Support tech transfer as engineering and equipment lead
• Project leadership: manage timelines and deliverables from project ideation through completion.
• Provide technical support for GMP manufacturing runs, supporting manufacturing through quality systems; deviations, CAPAs, & change controls.
• Drive continuous improvement projects
• Manage supplemental staff and vendor services on site
• Support maintenance procedure development and improvement
• Ownership of assets and changes within CMMS
• Coordinate as needed with counterparts at other manufacturing facilities for cross site alignment

KEY CHARACTERISTICS

The individual selected for this role must be an excellent collaborator, understanding how to communicate and participate in a team successfully.

• Hands-on, self-motivated
• Team player
• Willing and able to make decisions based on risk
• Reliable, driven, and organized
• Attention to detail, high concern for standards, and results oriented
• Excellent communication skills (oral and written)
• Able to multi-task effectively and proven ability to meet tight timelines

REQUIREMENTS FOR THE POSITION

• BS or MS degree in Chemical Engineering, Mechanical Engineering or related technical discipline.
• BS with 6 years minimum, 8+ preferred of experience or MS with 5+ years of experience in process engineering, manufacturing engineering or related field.
• Prior experience with process engineering, risk assessments, and quality systems in GMP environment, preferably with commercial or licensed products.
• Prior experience in single-use systems is a must, knowledge should encompass both upstream and downstream technologies.
• Aseptic manufacturing experience is preferred.
• Working knowledge of industry standard practices, FDA and EU regulations and GMP standards.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus. 
• In the performance of the duties of this job the employee is required to travel up to 25% of the time, drive a motor vehicle, communicate using telephone and e-mail.
• Able to work a flexible schedule.
• Lifting, walking, repetitive hand motions and attentiveness required
• The ability to gown and work successfully in a manufacturing environment