Associate Engineer, Drug Product Development Job at Piper Companies (Branchburg)

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Manufacturing support experience
Bachelor’s degree and 4 years of Manufacturing support experience
Associate’s degree and 8 years of Manufacturing support experience
High school diploma / GED and 10 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...

Location

United States , Thousand Oaks

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Manufacturing support experience
Associate’s + 2 years Manufacturing support experience
Bachelor’s + 6 months Manufacturing support experience
Master's
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior Product Engineer

This role oversees the entire product development lifecycle, from concept to pro...

Location

United States , Los Angeles

Salary:

130000.00 - 160000.00 USD / Year

Silvus Technologies (International)

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Electrical Engineering, Engineering Technology, or a closely related field
At least 6 years of extensive experience in mixed signal circuit design involving audio, SoCs, and Xilinx FPGAs, with demonstrated experience with complex mixed signal PCB design and HDI routing
Experience implementing digital communication peripherals at a hardware level, such as USB 3.0, 10Gb Ethernet, and RS232
Strong familiarity with test equipment such as DMM, bench top supply, oscilloscope, logic analyzer, and spectrum analyzer
Deep knowledge of product design principles, prototyping, and product testing (design verification and acceptance testing)
Familiarity with, and experience in, MIL-STD requirements and compliance testing
Strong ability to analyze data, perform root cause analysis, and make informed decisions
Excellent verbal and written communication skills to effectively interact with various teams and stakeholders
Strong skills in managing project timelines, coordinating resources, and leading teams to achieve product goals
Must be a U.S. Citizen due to clients under U.S. government contracts

Job Responsibility

Lead the design, development, and testing of new products, iterating the development with design engineers (EE, mechanical, and software) as well as product managers
Component selection, schematic capture, and PCB design of electrical systems based on an FPGA SoC with associated memory devices, transceivers, communication peripherals, and power management circuitry
Define PCB stack up, materials, and design rules to meet performance requirements and manufacturing feasibility
Perform hardware bring-up, test, and root cause analysis on the bench, using common lab equipment
Evaluate to determine risk assessments and mitigation paths (technical, schedule, and resources) across the design team, during the design process
Coordinate resources, identify and resolve technical challenges throughout the product development lifecycle, including design for manufacturing, build cost viability/analysis, transitioning from engineering into pre-production and production (BOMs, drawing updates, configuration management, test plans, etc.)
Plan, organize, and conduct product and system integration, testing, and validation, including support/conduct thermal testing/analysis, mechanical/electrical fit checks, FAAT, and related testing
Ensure product designs and implementation meet MIL-STD environmental, EMI, EEE, and human factors (e.g., MIL-STD-810, -461, -464, and -1472) specifications as appropriate by formulating test plans and outsourcing
Provide technical direction and mentor junior team members, as appropriate

Fulltime

Senior/Research Associate, Drug Product Development

We are seeking a skilled and motivated Senior/Research Associate to join our Del...

Location

United States , South San Francisco

Salary:

75000.00 - 100000.00 USD / Year

NewLimit

Expiration Date

Until further notice

Requirements

MS in Biomedical Engineering, Chemical Biology, Pharmaceutical Sciences, or a related discipline with 2+ years of industry experience or equivalent experience
Experience formulating LNPs with diverse lipid components for nucleic acid delivery
Experience with purification techniques, including dialysis, Tangential Flow Filtration (TFF), ultracentrifugation, and sterile filtration
Proficiency in LNP analysis using DLS, LC-UV, LC-CAD, CGE, fragment analyzers, Osmolality, MALS, ELISA, and fluorescence-based 96-well plate assays

Job Responsibility

Formulate, downstream process, and characterize LNPs for nucleic acid delivery across diverse model systems, including pre-clinical models
Partner with the Epigenetic Editing and Product teams (Immunology, Metabolism, Vascular) to meet LNP requirements for reprogramming interventions at both small and large scales
Develop and optimize LNP compositions, downstream processing and analytical methods to establish robust production protocols
Map future formulation needs, manage material procurement, and ensure the lab is equipped for upcoming programs
Interpret complex experimental data to drive decision-making within Delivery Science and Preclinical Development workstreams
Maintain rigorous and detailed records of experimental protocols and results in an Electronic Laboratory Notebook (ELN)

What we offer

Health, dental, and vision insurance
401(k) with company match
Paid parental leave
Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays
Meals and snacks on-site

Fulltime

Senior Manufacturing Systems Engineer: Automation - PLC

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience
Associate’s Degree and 8 years of Engineering experience
Bachelor’s Degree and 4 years of Engineering experience
Master’s Degree and 2 years of Engineering experience
Doctorate Degree
Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation
Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95

Job Responsibility

Provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations
Work hand in hand with the capital project team to deliver robust automation systems to operate the new plant utility and standalone systems
Develop and maintain automation solutions utilizing various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system
Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware
Lead and support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Lead in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems
Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions
Provide clear documentation for delivered solutions and processes
work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Device Engineer

The Senior Device Engineer serves as a technical leader in the design, developme...

Location

United States , Thousand Oaks

Salary:

123098.00 - 149145.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Engineering and/or Operations experience
Associate’s degree and 8 years of Engineering and/or Operations experience
Bachelor’s degree and 4 years of Engineering and/or Operations experience
Master’s degree and 2 years of Engineering and/or Operations experience
Doctorate degree
Degree in Mechanical, Biomedical, or related Engineering discipline
Extensive experience in medical device/combination product development, commercialization, and regulated manufacturing environments
Experience with products with ophthalmic indications
Experience with lifecycle management of commercialized medical devices or combination products
Proven ability to lead complex, cross-functional engineering programs from concept through launch

Job Responsibility

Serves as a technical leader in the design, development, and lifecycle management of drug delivery devices
Provides advanced engineering expertise, leads complex investigations, drives cross‑functional alignment, and influences decisions impacting Amgen’s strategic product portfolio
Accountable for ensuring that associated design history files for devices are robust, compliant, and strategically positioned for long-term sustainability
Seeks to enhance capabilities of the prefilled syringe and kit platform, evaluates and implements design changes as necessary, develops and strengthens technical standards, contributes to global product strategy and launches
Acts as a technical mentor to peers and junior engineers while representing the device engineering function across the broader Amgen network
Functions as a fully competent and highly independent subject-matter expert
Leads design and development efforts
Hosts and facilitates design reviews and assessments
Serves as a technical reviewer and approver for design documentation, analyses, and verification/validation packages
Directs system-level root cause investigations with cross-functional stakeholders

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior Manufacturing Systems Engineer: Automation

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience
Associate’s Degree and 8 years of Engineering experience
Bachelor’s Degree and 4 years of Engineering experience
Master’s Degree and 2 years of Engineering experience
Doctorate Degree
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform sophisticated troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95

Job Responsibility

Provide automation technical leadership to a group of automation engineers
Work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant
Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS)
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Collaborate with business partners to understand how automation can improve workflow and productivity
Synthesize requirements from clients, customers or end-users to develop the best automation solutions
Provide clear documentation for delivered solutions and processes
work closely with QA partners while supporting computerized systems validation processes in a GxP environment
Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime