Quality Control Environmental Monitoring Scientist II

Novo Nordisk; West Lebanon (NH); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Novo Nordisk is seeking a subject matter expert in industrial/pharmaceutical Environmental Monitoring for the West Lebanon site. The role ensures the EM program aligns with industry, regulatory and corporate standards, exercising independent judgment on methods while maintaining high GMP compliance.

The candidate will lead cross-functional EM support, audits, investigations and data analysis, with a focus on training and protocol development within a biotech/pharmaceutical setting.

Formación

• Bachelor’s degree in microbiology, biological sciences or related field.
• Master’s degree in microbiology, biological sciences or related field preferred.
• PhD in microbiology, biological sciences or related field preferred.

Responsabilidades

• Site lead for the Environmental Monitoring (EM) program at site NNUSBPI; oversees area monitoring and aseptic containment.
• Technical SME on microbiological assays, techniques and industry practices.
• Participates in site audits/inspections; responsible for area monitoring.
• Maintains GMP compliance; translates complex issues into actionable plans.
• Leads EM program development, risk assessments and data review/analysis.

Conocimientos

Staff management

Regulatory knowledge

IND/BLA experience

Project management

Communication skills

Educación

Bachelor’s degree in microbiology

Master’s degree preferred

PhD preferred

Descripción del empleo

About The Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life‑saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting‑edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient‑focused mindset guides everything we do. We’re looking for individuals who are self‑starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

About The Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life‑saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting‑edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient‑focused mindset guides everything we do. We’re looking for individuals who are self‑starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

This position is the subject matter expert on industrial/pharmaceutical Environmental Monitoring for the facility. Ensures facility program is in line with industry, regulatory and corporate practice. The individual exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP. Highly independent and self‑motivated, receives no instruction on routine work/prioritization and general instructions on new assignments. Skilled in matrix leadership, inspires others.

Relationships

Reports to: According to the organizational chart.

Number of subordinates with direct/indirect referral: n/a.

Essential Functions

• Site lead for the Environmental Monitoring (EM) program at site NNUSBPI. This includes area monitoring and aseptic contamination control programs and Quality risk assessment management
• Technical subject matter expert on microbiological assays, techniques and industry practices
• Participates in site audits and inspections from outside authorities; responsible for area monitoring
• High degree of understanding with respect to GMP and compliance; able to assimilate complex issues and distill recommendations into concrete actionable plans
• Collaborates cross functionally to provide EM support, this includes EM-program establishment/new construction support, investigation support, coordination of study support, EM based risk assessments and data review/analysis
• Leads training and education on basic microbiology and aseptic behaviour as needed
• Responsible for protocol and report generation to support area monitoring facility qualification
• Organizes and reviews EM trending data and writes reports summarizing the trends, independently
• Handles major deviations, CAPA investigations and corrective actions. Owns SPS and facilitates A3
• Investigates and resolves issues related assay failures, system deficiencies, deviations and equipment / assay troubleshooting, with no assistance
• Reviews/updates test method and program SOPs as needed
• Creates methods and procedures on new assignments as required
• Clean utility monitoring and risk assessment
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Other duties as assigned

Physical Requirements

0-10% overnight travel required. The ability to climb, balance, stoop, kneel, crouch, crawl, reach, stand and walk. The ability to push, pull, lift, finger, feel and grasp. The ability to speak, listen and understand verbal and written communication. Repetition including substantial movement of wrists, hands and or fingers. Lifting up to 33lbs/15kg of force occasionally and/or up to 30 pounds of force frequently and/or up to 10 pounds of force constantly to move objects. The worker is required to function in narrow aisles or passageways. Visual acuity to perform close activities such as: reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: inside and outside conditions including temperature changes; proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals, fumes, odours, dust, mists, gases, or poor ventilation.

Qualifications

• Education and Certifications:
  • Bachelor’s degree in microbiology, biological sciences or related field required
  • Master’s degree in microbiology, biological sciences or related field preferred
  • PhD in degree in microbiology, biological sciences or related field preferred
• Work Experience:
  • Bachelor’s degree with a minimum of eight (8) years in the pharmaceutical/biotech industry required
  • Master’s degree with a minimum of six (6) years in the pharmaceutical/biotech industry preferred
  • PhD degree with a minimum of two (2) years in the pharmaceutical/biotech industry preferred
  • Three (3) years of experience in project management activities and cross functional team coordination preferred
  • Desirable to have a minimum two (2) years of experience in a lead role within a biotech/pharmaceutical environmental monitoring program preferred
• Knowledge, Skills and Abilities:
  • Demonstrated ability to manage development associate staff is required
  • Prior experience authoring IND or BLA sections is desirable
  • Excellent written and oral communication and presentation skills. Excellent organizational skills

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.