Senior Manager, Engineering - Process

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.

The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards.

Process Engineering focuses on developing processes to minimize risks to the product.  The role works with industry experts/consultants to create design specifications, P&ID drawings, general arrangement drawings, user requirements, functional specifications, and automation control strategies. Provides technical solutions to complex problems by relying upon their experience and/or seeking recommendations from industry experts.

An Engineering Manager’s primary duty is to plan and direct all areas of engineering activities in a pharmaceutical manufacturing facility and to lead interdisciplinary teams in defining direction to meet the needs of internal and external customers.

Relationships

Reports to: Director or above

Direct Reports: 5 – 15

Total Site Staff (includes directs): 5 – 15

Essential Functions

• Manage multi-use facility process engineering function to assure best engineering practices
• Develop most effective preventative, predictive, and corrective maintenance is utilized
• Maintain minimal downtime
• Manage projects
• Work with various departments to implement compliance with FDA GMP requirements
• Ensure proper investigation and prompt closure of department deviations
• Draft SOPs for building operation, maintenance, and security
• Responsible for scheduling 24/7 coverage of the facility and alarm response
• Responsible for management of entire facility preventative maintenance
• Generate metric for both internal departments tracking and reporting to external departments
• Tracking of work orders to ensure completion by due date
• Review equipment trends to identify high failure items and remediate
• Provide guidance and execution on facilities and equipment projects
• Manage day to day facility activities, including supervision of the facility/maintenance staff
• Manage outside contractors
• Perform hands on activities as needed
• Lead team members to improve and reinforce performance of others
• Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
• Adapts departmental plans and priorities to address resource and operational challenges
• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
• Other duties as assigned

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 condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

Qualifications

• Education/Experience:
  • Bachelor’s degree in Chemical/Mechanical/Electrical Engineering, required
  • Master’s degree, preferred
  • 10+ years of relevant Project Engineering experience
  • 5+ years in a regulated industry (Life Sciences, preferred)
  • OSHA 10 or equivalent, preferred
  • PE/Registered Engineer, Preferred
  • Prior Supervisory Experience

• Technical Requirements:
  • Background in management aseptic 1 filling process.
  • Proficiency with process definition, project management, strong communication skills, and proven ability to be a team leader
  • Familiarity with regulatory requirements (cGMP) for biopharmaceutical production
  • Word processing and spreadsheets skills, engineering software such as AutoCad or equivalent
  • Knowledge of PLC programs and compliant control systems
  • Good oral and written communication skills

• Behavioral Requirements:
  • Ability to see and hear, read, and write clear English
  • Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing
  • 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, in a professional and accurate manner
  • 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 with ability to work effectively under high pressure with multiple deadlines
  • Strong ability to multi-task in a fast pace environment
  • Positive attitude and ability to work with others
  • Ability to process a large volume of work
  • Ability to effectively carry out and implement change
  • Ability to put aside personal opinions and focus on business needs, department needs, or group needs

• Leadership Requirements:
  • Establishes an effective, professional, and positive relationship with employees
  • Clarifies responsibilities and expectations and holds employees accountable
  • Participates in and conducts timely HR-related processes
  • Provides timely constructive feedback that is clear and direct
  • Provides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performance

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.