Specialist II, Form/Fill

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.  

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.

Primary – Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, material staging, and aseptic filling. Product in this area is filled into vials, syringes, or cartridges inside sterile isolator barriers.  The sterile barrier isolator provides a physical barrier between the manufacturing equipment and the personnel controlling the machine. The Drug Product Primary Manufacturing area is a cleanroom environment. Personnel working in this area are required to wear scrubs and/or coveralls, gloves, hairnet, safety glasses, and steel toed shoes.

Secondary – The Secondary Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, complex and bulk packaging. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

Drug Substance - The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The Position

In general, this position provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner.

Relationships

Reports to:  Manager, Form/Fill

Shift:  Weekdays AM, 4/3 Schedule for SL3

Essential Functions

• Evaluate, identify, and implement improvements needed for processes and procedures
• Provide direct technical support for production processes and implementation of improvements
• Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP and document revision, review and approval
• Lead and participate in continuous improvement process changes
• Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience
• Direct interaction with Client and Regulatory Auditors
• Lead and guide all tours related to client and regulatory audits
• Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
• Proposes improvements to processes and methods
• Works autonomously within established procedures and practices
• Competent at-risk mitigation for function
• Write and revise SOP’s and WI’s
• Support or own work orders, deviations, and audit observations for equipment activities
• Provide training support for equipment set-up, operation, and changeover
• Actively participates, suggests solutions to problems, and drives to timelines
• Ensure documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities
• Create and assist in implementation of Corrective and Preventative Actions (CAPAs)

• Primary:
  • Has developed exceptional knowledge in a range of processes or procedures through job-related training and considerable on-the-job experience
  • Completes a variety of atypical assignments, as needed
  • Completes work autonomously
  • Subject matter expert for processes and procedures within primary manufacturing
  • Proposes process improvements related to equipment and processes
  • Collaborates with Production Supervisors, Room Leads, and QA floor support to solve issues real time
  • Provides technical expertise for machine setup, troubleshooting, and maintaining overall efficiency
  • Assists with training operators in all aspects of primary manufacturing
  • Review and approve documents in EDMS
  • Revise, and route documents through EDMS
  • Executes other duties as assigned

• Secondary:
  • Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience
  • Review and approve documents in EDMS
  • Revise department documents, and route through EDMS
  • Provides technical and floor support when required, and able to assist in basic troubleshooting of process and equipment
  • Proposed process improvements and equipment improvements to MS&T, Engineering, and QA as applicable
  • Collaborates with Supervisors, Room Leads, QA to solve issues real-time
  • Executes other duties as assigned
• Drug Substance:
  • Equivalent technical expertise of process and equipment with that of Senior Manufacturing Associate
  • Review and approve documents in EDMS
  • Revise department documents, and route through EDMS
  • Review and approve new client batch records
  • Create, review, and revise process overviews, and process descriptions
  • Supports training for new processes and procedures as it relates to new and existing customer programs
  • Review and revise consumable designs and vendor drawings
  • Work directly with vendors on design of new consumable items, as well as implementation at Catalent site (MSS creation, IM setup, etc.)
  • Provides technical and floor support when required, and able to assist in basic troubleshooting of process and equipment
  • Propose process improvements and equipment improvements to MS&T, Engineering, and QA as applicable
  • Supports deviation investigators, and audit teams in CAPA implementation and creation
  • Performs deviation investigations within track wise
  • Drive strategic continuous improvement (CI) programs to optimize systems and processes within Manufacturing operations
  • Provide executional feedback to PD and MS&T to drive revision of MBR's and continuous improvement
  • Assist operators in with IT related issues, and offers suggestions for new/improved equipment
  • Assist QA Batch Record Review with Client Observations, including priority observations from QA Client Support Team
  • Collaborates with Supervisors, Room Leads, QA to solve issues real-time
  • Provides on-call support for alarm management and troubleshooting, as necessary
  • Creates and administers training content to elevate technical knowledge on team
  • Works scheduled shift and other off-shift coverage as required
  • Executes other duties as assigned
  • Ability to read and write English
  • Perform basic math skills (+, -, x, /, %, understand decimals)
  • Required to read, understand, and follow GMP documents
  • Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry)
  • Works independently on limited scope issues

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

Qualifications

• Education/Experience:
  • High School/GED required
  • 5 years pharmaceutical and/or manufacturing experience required
  • 5 years GMP experience required
• Technical Requirements:
  • Proficient in Excel, Word, and other office systems
  • Prior work experience with quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards®, DeltaV®, Chromatography (i.e. Unicorn®), etc.
  • Ability to understand and independently apply CGMPs as it relates to clinical and commercial operations
  • Demonstrates understanding of the work tasks assigned
  • Executes complex with high quality
  • Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines
  • Intermediate understanding of pharmaceutical laboratory and/or production operations
  • Capable of learning unfamiliar principles or techniques with training
  • Prior experience leading deviation investigations using root cause analysis tools
  • Champion change control and corrective / preventative actions
  • Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions
  • Authors and/or approves Standard Operating Procedures (SOPs), Batch Production Records (BPRs) and reports
  • Ability to lead technical calls and discussions regarding investigations, audits, or other issues
  • Seeks best practices for daily work activities
  • Ability to support Risk Assessments, especially Hazard Analysis, Fault Tree Analysis, FMEA, etc.

• Behavioral Requirements:
  • Ability to see and hear and read and write clear English
  • Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary
  • Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  • Ability to cooperate with coworkers within an organized team environment or work alone
  • Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
  • Ability to put aside personal opinions and focus on business needs, department needs or group needs
  • Ability to transfer knowledge to others via training or mentoring
  • Demonstrated ability to guide others thorough communication and learning
  • Ability to make decisions which have moderate impact on immediate work unit
• Leadership Requirements:
  • Leads by example according to Catalent's values and culture
  • Builds on contacts and relationships with peers
  • Takes initiative for personal and professional development
  • Takes initiative when necessary to address changes in scope and procedural errors
  • Builds trust and respect for self and department

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.