BioSpace, Inc.
Engineering Area Specialist (Technical Writer)
BioSpace, Inc., West Lebanon, New Hampshire, us, 03784
Job Details
About the Department
Site New Hampshire, located in West Lebanon, NH, 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 positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option12 weeks Paid Parental LeaveFree 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
The primary responsibilities of the Engineering Area Specilist are to support technical operations. Assist in coordination and execution of processes and equipment improvement programs, investigate deviations, and implement corrective/preventative actions via change requests, document change controls, and develop training.
Relationships
Reports to: Lead Engineer
Number of subordinates with direct/indirect referral: None
Essential FunctionsLiaison between Engineering and manufacturing for the coordination of process/equipment improvementsAbility to investigate and write up Deviations events utilizing Root Cause AnalysisUtilize the quality system to implement changes associated with technical operations, engineering, and/or validation (generate, execute, and evaluate change requests)Revise and create documentation (SOP, batch records, reports) associated with technical operations, production, engineering, and validationIncorporate technical pre-planned process improvements and cost reduction projects into manufacturingDevelop training for engineering/validation or production with direction from engineersSupport Health Authority inspections and internal auditsAbility to take on and manage multi-disciplined projects, with minimal supervisionWork on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality AssurancePerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with othersOther duties as assigned
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. Visual acuity to perform close activities such as: reading, writing, and analyzing. Lifting up to 33 lbs/15 kg 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 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%.
QualificationsEducation and Certifications:
Associate's Degree in a Business or technicial field, or equivalent combination of education & experience required.Bachelors degree preferred.
Work Experience:
4+ years of experience in technicial writing, preferably in engineering, life sciences, software or related industries required with an Associates Degree.Two (2) years experience with a Bachelors degree preferred
Knowledge, Skills, and abilities:
Ability to follow routine work instructions for new and ongoing projects and assignmentsExcellent communication skills and ability to work in a high-paced team-oriented environmentRequires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelinesAbility to understand and execute established written instructions is essentialOrganizational skills and an ability to perform assignments with a high degree of attention to detailDemonstrate a practical understanding of lean manufacturing principlesAnalytical abilities and problem-solving skillsA strong work ethic (self-motivated), honesty, excellent communication skills, and the ability to work in teams - displays initiative and commitment
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.
About the Department
Site New Hampshire, located in West Lebanon, NH, 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 positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option12 weeks Paid Parental LeaveFree 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
The primary responsibilities of the Engineering Area Specilist are to support technical operations. Assist in coordination and execution of processes and equipment improvement programs, investigate deviations, and implement corrective/preventative actions via change requests, document change controls, and develop training.
Relationships
Reports to: Lead Engineer
Number of subordinates with direct/indirect referral: None
Essential FunctionsLiaison between Engineering and manufacturing for the coordination of process/equipment improvementsAbility to investigate and write up Deviations events utilizing Root Cause AnalysisUtilize the quality system to implement changes associated with technical operations, engineering, and/or validation (generate, execute, and evaluate change requests)Revise and create documentation (SOP, batch records, reports) associated with technical operations, production, engineering, and validationIncorporate technical pre-planned process improvements and cost reduction projects into manufacturingDevelop training for engineering/validation or production with direction from engineersSupport Health Authority inspections and internal auditsAbility to take on and manage multi-disciplined projects, with minimal supervisionWork on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality AssurancePerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with othersOther duties as assigned
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. Visual acuity to perform close activities such as: reading, writing, and analyzing. Lifting up to 33 lbs/15 kg 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 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%.
QualificationsEducation and Certifications:
Associate's Degree in a Business or technicial field, or equivalent combination of education & experience required.Bachelors degree preferred.
Work Experience:
4+ years of experience in technicial writing, preferably in engineering, life sciences, software or related industries required with an Associates Degree.Two (2) years experience with a Bachelors degree preferred
Knowledge, Skills, and abilities:
Ability to follow routine work instructions for new and ongoing projects and assignmentsExcellent communication skills and ability to work in a high-paced team-oriented environmentRequires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelinesAbility to understand and execute established written instructions is essentialOrganizational skills and an ability to perform assignments with a high degree of attention to detailDemonstrate a practical understanding of lean manufacturing principlesAnalytical abilities and problem-solving skillsA strong work ethic (self-motivated), honesty, excellent communication skills, and the ability to work in teams - displays initiative and commitment
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.