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Novo NordiskCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in operating utility and raw material systems within regulated environments, adhering to GMP and cGMP standards while ensuring safety and compliance. Proficient in systematic problem-solving and maintaining operational efficiency through effective stakeholder collaboration.
Highest-signal resume keywords
Utility And Raw Material Systems OperationGMP And cGMP ComplianceSystematic Problem-SolvingElectronic Batch Records ManagementRegulated Industry Experience
About the role
Key responsibilities & impact- Operate utility and RMS process equipment to support API-US production
- Operate equipment and processes according to Standard Operating Procedures for nGMP and GMP systems
- Identify and document system or operational anomalies to minimize downtime and ensure a safe working environment
- Maintain standards and operational procedures for automated and manually operated systems
- Support operation, maintenance and response for control systems including BMS, PCS and Life Safety
- Support stakeholders with plant operations, maintenance and optimization activities
- Execute raw material movement and offload into process systems
- Conduct site rounds and equipment inspections independently
- Adhere to Quality, Environmental Health & Safety and other regulatory requirements
- Participate in systematic problem-solving efforts
- Manage individual training plan
- Perform routine cleaning and housekeeping in assigned areas
- Review electronic batch records in real time for SOP and cGMP compliance
- Report to the Manager
- Establish and maintain positive relationships with internal and external stakeholders
- Perform other assigned accountabilities
Requirements
What you’ll need- High school graduate or GED required
- Bachelor’s Degree in a relevant field of study from an accredited university preferred
- BioWork certification or equivalent a plus
- Minimum of 6 months of related experience in regulated industry required
- Knowledge and experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA) a plus
- Experience demonstrating a systematic approach to problem solving and troubleshooting based on data and facts
- Active participation in and driving of event response activities preferred
- Experience documenting problems and working on rapid resolution and recurrence prevention preferred
- Basic knowledge of production utility systems or raw material handling, such as purified water, process air, chemical storage and process waste systems preferred
- Ability to work with electronic batch records, automated process equipment and/or DeltaV or Syncade preferred
- Ability to read/review equipment documents with a basic understanding preferred
- Understanding of complicated product documentation and standard operating procedures with attention to high-level concepts a plus
- Computer literacy with associated systems required
- Proven ability to check results and revise work tasks to meet daily plan preferred
- Ability to stand for up to a 12-hour shift
- Ability to move equipment and supplies weighing up to 33 pounds
- Ability to work in loud-noise environments with hearing protection and around hazardous materials as required
- May be required to secure a motorized vehicle license and operate a motorized vehicle based on the role
Benefits
Comp & perks- Leading pay and annual performance bonus for all positions
- 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
- 14 weeks paid parental leave
- 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
- Opportunities, resources, and mentorship to help grow and build your career
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process Equipment OperationQuality Control ProceduresData Analysis And TroubleshootingRaw Material HandlingAutomated Process EquipmentDocument Review And ComplianceEquipment InspectionHousekeeping ProceduresTraining Plan ManagementEvent Response Activities
Soft Skills
Relationship BuildingCommunication SkillsTeam CollaborationAttention To DetailAdaptability
Tools & Technologies
DeltaVSyncadeBMSPCSElectronic Batch Records Systems
Certifications & Qualifications
BioWork CertificationHigh School Diploma Or GED
Industry Keywords
FDA RegulationsOSHA ComplianceEnvironmental Health And SafetyNGMP StandardsRegulated Industry Experience