Process Professional II - API manufacturing

BioSpace; Petersburg (VA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with match

Parental leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Product access

Job summary

Novo Nordisk is seeking a Site Subject Matter Expert (SME) for the Operations department at the Petersburg, Virginia site. You will provide GMP knowledge, lead strategic projects, coach Process Professionals, and coordinate with stakeholders to meet cost, quality, and schedule targets.

Responsibilities include investigations, root-cause analysis, continuous improvement via Lean and Six Sigma, and maintaining area master data and recipes. Travel up to 20% may be required.

Qualifications

• Bachelor’s degree (engineering, technology or related field) required; 3 years manufacturing exp. in pharma preferred.
• In lieu of Bachelor’s, Associate’s with 5 years manufacturing exp. or High School with 7 years exp.
• Excellent written communication skills required; strong problem-solving abilities.

Responsibilities

• Provide GMP knowledge and strategic support as Site SME for Operations.
• Lead projects and communicate status to Senior Management.
• Coach/mentor Process Professionals and collaborate with site stakeholders.
• Identify improvement opportunities and manage master data and recipes.

Skills

LEAN manufacturing

Six Sigma

Root cause analysis

Process knowledge

Education

Bachelor’s degree (engineering/related field)

Associate’s degree (engineering/related field)

High School Diploma or equivalent

Tools

SAP

PAS-X

Job description

About The Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

About The Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What We Offer You

• 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
• Tuition Assistance
• Life & Disability Insurance
• 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 Position

Provide GMP knowledge and strategic support to the organization as the Site Subject Matter Expert (SME) for the Operations department. Lead and support various projects as required based on evolving business needs as it relates to GMP and quality within the operations department. Act as a coach/mentor to area Process Professionals. Communicate on behalf of Novo Nordisk with stakeholders related to projects and production. Complete assigned projects and project tasks within cost, quality and schedule requirements. Present project status updates to Senior Management.

Relationships

Reports to Manager/Director. The role is responsible for collaborating with stakeholders related to assigned area as well as other stakeholders across the site and other NN sites.

Essential Functions

• Support senior leadership as part of the department management group through participating in strategic discussions and decision making
• 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 dutiesOther duties as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case by case basis based on the role).

Qualifications

• Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required and a minimum of three (3) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
• In lieu of Bachelor’s degree plus three (3) years of experience, may consider an Associate’s degree (engineering, technology or related field of study preferred) in technology or related field of study from an accredited college or university with a minimum of five (5) years of manufacturing experience required
• In lieu of Bachelor’s degree plus three (3) years of experience, may consider a High School Diploma or equivalent with a minimum of seven (7) years of manufacturing experience required. 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

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.