Production Support Specialist II (Sterility Assurance/Aseptic expertise preferred!)

Location
Libertyville, IL, US
Posted
May 04, 2021
Ref
5993
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Production Support Specialist II is responsible for the investigation and completion of non-conformances aimed at identification of root cause, assessing potential impact as well as implementation of corrective actions and preventive actions.

Responsibilities
  • Identifies and leads continuous improvement projects using Six Sigma methodologies and conduct risk assessments.
  • Initiate, own, and drive change controls related to manufacturing operations.
  • Authoring of minor, major, and critical investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering.
  • Work on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing employees.
  • Conduct personnel interviews and system reviews; act as an unbiased investigator with questions surrounding the specific issue.
  • Perform appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams).
  • Assign and implement proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
  • Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
  • Remain current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
  • Management of multiple projects and timelines concurrently.
  • Adhere to standard timelines and escalate actions appropriately for resolution in a timely manner.
  • Initiate, own, and drive complex change controls related to manufacturing operations.
  • Utilize appropriate risk management tools for recommendation on disposition of materials.
  • Support Annual Product Reviews by assisting in the data collection from Manufacturing and preparation of necessary documentation.
  • Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records, change controls, training documentations, protocols and white papers.
  • Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).
  • Track, trend and facilitate manufacturing related deviations, investigations, change controls and CAPAs.
  • Perform and conduct risk assessments.
  • Coordinate and develop detailed production schedule for day to day manufacturing operations/activities to increase efficiency and productivity. Develop weekly production status reports. Help with plant capacity and shutdown activities.
  • Support the continuous improvement program for the manufacturing process. Provide coordination of activities relating to Continuous Improvement and enhancing knowledge of the tools and techniques of Continuous Improvement / Lean methods.
  • Identify opportunities in manufacturing and execute Continuous Improvement activities.
  • Support strategic proposals, progress updates and presentations to all levels of the site organization.
  • Other related job duties as assigned.

Qualifications
  • Bachelor of Arts/Science or equivalent combination of education and work experience and 6 years of relevant experience.
  • Working knowledge of biopharmaceutical manufacturing processes, sterility assurance/aseptic practice expertise preferred. Prior experience in microbiology also preferred.
  • Ability to manage multiple ongoing projects concurrently.
  • Strong meeting facilitation and conflict resolution skills.
  • Strong technical writing capability.
  • Action oriented and compliant minded while performing investigations.
  • Understand and problem solve in an environment that is focused heavily on Chemical and Biological issues.
  • Understanding of the concepts incorporated in Quality Assurance in a GMP environment.
  • Skills in statistics are required to effectively analyze trends.Prior experience in quality investigations and deviation writing in a manufacturing environment.
  • Manufacturing experience, specifically upstream and downstream processing, in a GMP environment is preferred.
  • Six Sigma Yellow, Green or Black Belt certification preferred.
  • Proven ability to work in a fast paced, high workload environment, and manage multiple projects and objectives for on-time event closure.
  • Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.
  • Must be proactive, action oriented and adaptable to change.
  • Proven ability to identify and flag risks in a timely manner to keep deliverables on track.
  • Strong communication skills both verbally and written.
  • Proven logic and decision-making abilities and critical thinking skills.
  • Ability to accommodate manufacturing schedule as required.
  • Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.