Support people, equipment and processes for our operations areas to meet business and regulatory requirements.
Support training for lower-level peers.
Demonstrate subject matter expertise in assigned area.
Provide process solutions for moderate to high complexity issues.
Serve as a back-up as needed for the Senior Process Professional and as a mentor/coach for junior team members.
Responsible for providing in depth deviation investigations and root cause analysis
Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications
Responsible for area content and process knowledge
Identify and implement process needs and improvement opportunities for moderate to high complexity issues
Responsible for periodic reviews and reporting.
Involved with collaboration across sites
Update and manage area master data and recipes as needed
Provide support on defined issues and contributes through application of expertise and knowledge
Follow all safety & environmental requirements in the performance of duties
Requirements
Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required
May consider an Associate’s degree (engineering, technology or related field of study preferred) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
Excellent written communication skills required
Thorough investigation and systematic problem-solving experience required
LEAN manufacturing experience and training required
General knowledge of change control systems and Quality Management Systems (QMS) required
Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.)
Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred
General experience with regulatory audits/inspections required
Knowledge of relevant master data preferred
Validation experience preferred
Product transfer (or tech transfer) experience a plus
Benefits
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products