What are the responsibilities and job description for the Process Engineer Level I-II (Downstream) position at BioSpace?
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.
What We Offer You
Leading pay and annual performance bonus for all positions
36 Paid days off including vacation, sick days & company holidays
Health Insurance, Dental Insurance, Vision Insurance
Guaranteed 8% 401K contribution plus individual company match option
14 weeks Paid Parental Leave
Free access to Novo Nordisk-marketed pharmaceutical products
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 role will be part of our bioproduction downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative maintenance and equipment repairs are carried out correctly. May be responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer will work alongside Process Associates and Process Scientists and may support day to day issues in manufacturing such as: deviation investigations, CAPAs, equipment troubleshooting, small scale process development, SOP review, escalating complex issues to appropriate stakeholders, or participating in process confirmations on the shop floor. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API onsite. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. Prior experience in a GMP environment or life science industry is a plus for this role.
The job level and title of hired candidate will be commensurate with experience. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH.
Relationships
Reports to: Manager, Process Support (Downstream)
Essential Functions
Assist with SOPs, JIs, DVs and other production documentation to the shopfloor
Participate in the development and implementation of procedural or automation improvement changes
Participate in production-driven improvements to the process and equipment on shopfloor. Drive an own minor improvement initiatives and support colleagues
Develop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections
Maintain effective communication and ensure alignment in coordination with appropriate teams
Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements
Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations
Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification, and validations
Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as needed
Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
Participate in on-call rotations, including weekends and non-business hours, to provide support
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
Qualifications
Education and Certifications:Bachelor’s degree in engineering or related discipline required
Work Experience:Bachelor’s degree with three (3) years related experience required
Medium to large scale pharmaceutical or biotechnology process experience preferred
Knowledge, Skills, and Abilities:Ability to follow routine work instructions for new and ongoing projects and assignments
Knowledge of Automation and GMPs requirements preferred
Broad understanding of science and risk-based verification (I.E. ASTM E2500)
Knowledge of good engineering practices
Excellent written and verbal communication skills a must
Excellent communication skills and ability to work in a high-paced team-oriented environment
Ability to provide evening, nighttime, and weekend on call support as needed
Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred
Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes
Physical Requirements
The ability to climb. 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. Visual acuity to perform close activities such as: reading, writing, and analyzing; and visual inspection. The working environment includes a variety of physical conditions including noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including odors, fumes, and dust. Local and International Travel: 0-10%.
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
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.
What We Offer You
Leading pay and annual performance bonus for all positions
36 Paid days off including vacation, sick days & company holidays
Health Insurance, Dental Insurance, Vision Insurance
Guaranteed 8% 401K contribution plus individual company match option
14 weeks Paid Parental Leave
Free access to Novo Nordisk-marketed pharmaceutical products
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 role will be part of our bioproduction downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative maintenance and equipment repairs are carried out correctly. May be responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer will work alongside Process Associates and Process Scientists and may support day to day issues in manufacturing such as: deviation investigations, CAPAs, equipment troubleshooting, small scale process development, SOP review, escalating complex issues to appropriate stakeholders, or participating in process confirmations on the shop floor. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API onsite. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. Prior experience in a GMP environment or life science industry is a plus for this role.
The job level and title of hired candidate will be commensurate with experience. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH.
Relationships
Reports to: Manager, Process Support (Downstream)
Essential Functions
Assist with SOPs, JIs, DVs and other production documentation to the shopfloor
Participate in the development and implementation of procedural or automation improvement changes
Participate in production-driven improvements to the process and equipment on shopfloor. Drive an own minor improvement initiatives and support colleagues
Develop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections
Maintain effective communication and ensure alignment in coordination with appropriate teams
Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements
Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations
Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification, and validations
Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as needed
Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
Participate in on-call rotations, including weekends and non-business hours, to provide support
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
Qualifications
Education and Certifications:Bachelor’s degree in engineering or related discipline required
Work Experience:Bachelor’s degree with three (3) years related experience required
Medium to large scale pharmaceutical or biotechnology process experience preferred
Knowledge, Skills, and Abilities:Ability to follow routine work instructions for new and ongoing projects and assignments
Knowledge of Automation and GMPs requirements preferred
Broad understanding of science and risk-based verification (I.E. ASTM E2500)
Knowledge of good engineering practices
Excellent written and verbal communication skills a must
Excellent communication skills and ability to work in a high-paced team-oriented environment
Ability to provide evening, nighttime, and weekend on call support as needed
Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred
Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes
Physical Requirements
The ability to climb. 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. Visual acuity to perform close activities such as: reading, writing, and analyzing; and visual inspection. The working environment includes a variety of physical conditions including noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including odors, fumes, and dust. Local and International Travel: 0-10%.
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.