Operational leadership of the FLEx complex, which supports end-to-end GMP clinical supply manufacture and product/process development for oral and injectable therapeutics and vaccine drug products.
Locations (3)
Rahway, New Jersey, United States
San Francisco, California, United States
Los Angeles, California, United States
Compensation
The salary range for the primary location of this role is: $231,900.00 - $365,000.00
Responsibilities
Setting of a strategic vision for FLEx aligned to the PSDD and company's research division strategies
Overseeing operations in the set of FLEx assets
Creating an entrepreneurial culture in FLEx
Collaborating with peer leaders across research, manufacturing and corporate divisions
Establishing and managing financial budgets and forecasts associated with the FLEx assets
Requirements
BS or MS degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field with 10 years of relevant experience
PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with 8 years of relevant experience
Lead, coach, and mentor shift process teams to execute production plans in order to meet quality, customer and business objectives.
Compensation
Leading pay and annual performance bonus for all positions
Responsibilities
Lead, coach, and mentor shift process teams to execute production plans to meet quality, customer and business objectives
Create a safe, productive, and engaging workplace
Promote adherence to all quality objectives, specifications, and requirements
Coach and mentor work cell leaders, operations area specialists, quality improvement specialists, process team members & technical area specialists
Provide direction, prioritization, and motivation for all shift team members
Requirements
Bachelor’s degree from an accredited university with a minimum of three (3) years of experience in a manufacturing organization required, preferably pharmaceutical manufacturing
Associate’s degree from an accredited university with two (2) additional years of experience in a manufacturing environment, preferably pharmaceutical manufacturing
High School diploma or GED with four (4) additional years of experience in a manufacturing environment, preferably pharmaceutical manufacturing
Nice to have: Aseptic Processing
Nice to have: Ability to read, write and understand complicated product documentation and standard operating procedures
Own the design, configuration, implementation, and continuous improvement of PAS-X solutions supporting electronic batch records, paperless manufacturing, and GMP-compliant production operations.
Compensation
The salary for this position is expected to range between $85,400 and $158,600 annually
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
Responsibilities
Design, build, test, and maintain PAS-X electronic Master Batch Records and electronic batch records
Configure PAS-X workflows, recipes, paperless instructions, and manufacturing process controls
Serve as the site PAS-X SME supporting manufacturing operations and shop floor users
Troubleshoot MES and PAS-X issues to minimize production disruptions and improve system performance
Partner with Manufacturing, Quality, Validation, Automation, and IT teams on MES initiatives
Requirements
Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field
Join Novartis and help shape the future of digital manufacturing through PAS-X MES technology. As an MES Specialist, you will own the design, configuration, implementation, and continuous improvement of PAS-X solutions that support electronic batch records, paperless manufacturing, and GMP-compliant production operations.
Compensation
The salary for this position is expected to range between $85,400 and $158,600 annually
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Responsibilities
Design, build, test, and maintain PAS-X electronic Master Batch Records and electronic batch records
Configure PAS-X workflows, recipes, paperless instructions, and manufacturing process controls
Serve as the site PAS-X SME supporting manufacturing operations and shop floor users
Troubleshoot MES and PAS-X issues to minimize production disruptions and improve system performance
Partner with Manufacturing, Quality, Validation, Automation, and IT teams on MES initiatives
Requirements
Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field
Operate, monitor, and maintain manufacturing equipment in a cGMP-regulated environment to produce high-quality products safely, efficiently, and in compliance with established procedures.
Compensation
competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.
Responsibilities
Operate, monitor, and maintain manufacturing equipment in a cGMP-regulated environment to produce high-quality products safely, efficiently, and in compliance with established procedures.
Perform material handling, weighing, processing, inspection, and in-process quality checks while monitoring critical process parameters to ensure product specifications and quality standards are met.
Execute equipment setup, cleaning, sanitization, and changeovers to support production schedules and maximize operational efficiency.
Troubleshoot equipment issues, perform basic adjustments and minor repairs, replace worn or malfunctioning components, and escalate complex issues to technical support teams as needed.
Support preventive and predictive maintenance activities to improve equipment reliability and minimize downtime.
The Quality Assurance Specialist II provides Quality Assurance oversight for manufacturing and operational activities within a biopharmaceutical or pharmaceutical environment. The role is responsible for batch record review and release support, area release activities, review of electronic systems and manufacturing records, assessment of quality events, and execution of routine compliance activities.
Compensation
The annual base pay for this position ranges from $79,890 to $119,835. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Responsibilities
Perform batch review and release activities for paper-based batch records and electronic batch records (EBRs)
Perform or support area release activities
Conduct area audits on a quarterly basis
Prepare and review lot genealogy reports
Provide backup support to the Quality Systems function
Requirements
Bachelor’s degree
Bachelor’s degree in biology, engineering, or a related scientific or technical field
The Quality Assurance Specialist II provides Quality Assurance oversight for manufacturing and operational activities within a biopharmaceutical or pharmaceutical environment, responsible for batch record review and release support, area release activities, and assessment of quality events.
Compensation
The annual base pay for this position ranges from $79,890 to $119,835. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Responsibilities
Perform batch review and release activities for paper-based and electronic batch records
Perform or support area release activities
Conduct area audits on a quarterly basis
Prepare and review lot genealogy reports
Provide backup support to the Quality Systems function
Requirements
Bachelor’s degree
Bachelor’s degree in biology, engineering, or a related scientific or technical field
The DeltaV Process-CSV/DCS Engineer supports the design configuration validation and lifecycle management of Emerson DeltaV DCS in a GxP-regulated life science manufacturing environment.
Responsibilities
Configure modify and maintain DeltaV control modules phases recipes alarms and graphics in line with ISA-88 batch standards
Prepare and execute CSV deliverables per GAMP 5 including URS FS/DS risk assessments IQ/OQ/PQ protocols and traceability matrices
Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements including security audit trails and electronic signatures
Support integration of DeltaV with Syncade or PAS-X MES historians OPC servers and PLC/SCADA-based equipment
Provide L2/L3 support troubleshoot control system issues and perform root cause analysis to minimize process downtime
Aseptic Process Specialist responsible for aseptic filling procedures, GMP compliance, and sterile environment maintenance at Zoetis Atlanta biologics manufacturing site.
Responsibilities
Perform aseptic filling procedures
Ensure adherence to GMPs
Maintain sterile environment
Document processes
Operate specialized equipment
Requirements
Associates degree required
Bachelor's degree preferred in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology or related technical field
Nice to have: Biological antigen production systems
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