Senior Manager Manufacturing Programs - Investigations and Process Ownership Job at Amgen (Holly Springs)

Senior Factory Automation Engineer

We are seeking a highly motivated Senior Factory Automation Engineer to join our...

Location

United States , Provo

Salary:

Not provided

Dandy

Expiration Date

Until further notice

Requirements

Bachelor's Degree – Chemical, Electrical, Mechanical, or Materials Engineering from a four-year university
Minimum of six years of experience as a Manufacturing or Process Engineer, or similar role
Equipment ownership from enablement through long-term sustainability
Proven ability to evaluate, develop and manage process parameters in the manufacture of products
Demonstrated ability to define problems, collect data, establish facts, and draw valid conclusions
Demonstrated ability to interpret extensive abstract and concrete variables
Excellent oral and written communication skills, with ability to speak effectively before groups of customers or employees of the organization
Current computer literacy including Microsoft Word, Excel, and PowerPoint
Experience in Lean Manufacturing and/or Six Sigma continuous improvement programs
Experience with SPC and other statistical techniques

Job Responsibility

Participate in design reviews for automated equipment development
Lead all factory integration activities required to receive new, automated equipment. Support all new equipment testing and qualification
Become an equipment owner and expert. Responsible for sustaining equipment performance and continuous improvement
Monitor equipment health and use data to identify root cause and corrective actions (RCCA)
Lead systematic, cross-functional efforts to sustain high Overall Equipment Efficiency (OEE)
Evaluate processing conditions and resultant material properties and troubleshoot as necessary utilizing SPC techniques
Assume full responsibility for managing process conditions to meet Process Control Document requirements and mechanical and physical properties
Implementation and operation of mechanical and electromechanical systems
Actively pursue and direct process improvements to improve performance, cost, etc
Solve problems using cross-functional teams with tools such as DMAIC and Design of Experiments (DOE)

What we offer

healthcare
dental
mental health support
parental planning resources
retirement savings options
generous paid time off

Fulltime

Senior Factory Automation Engineer

This is a high-impact, challenging role dedicated to co-engineering and maintain...

Location

United States , Carrollton

Salary:

104550.00 - 148000.00 USD / Year

Dandy

Expiration Date

Until further notice

Requirements

Bachelor's Degree – Chemical, Electrical, Mechanical, or Materials Engineering from a four-year university
Minimum of six years of experience as a Manufacturing or Process Engineer, or similar role
Equipment ownership from enablement through long-term sustainability
Proven ability to evaluate, develop and manage process parameters in the manufacture of products
Demonstrated ability to define problems, collect data, establish facts, and draw valid conclusions
Demonstrated ability to interpret extensive abstract and concrete variables
Excellent oral and written communication skills, with ability to speak effectively before groups of customers or employees of the organization
Current computer literacy including Microsoft Word, Excel, and PowerPoint
Experience in Lean Manufacturing and/or Six Sigma continuous improvement programs
Experience with SPC and other statistical techniques

Job Responsibility

Participate in design reviews for automated equipment development
Lead all factory integration activities required to receive new, automated equipment
Support all new equipment testing and qualification
Become an equipment owner and expert
Monitor equipment health and use data to identify root cause and corrective actions (RCCA)
Lead systematic, cross-functional efforts to sustain high Overall Equipment Efficiency (OEE)
Evaluate processing conditions and resultant material properties and troubleshoot as necessary utilizing SPC techniques
Assume full responsibility for managing process conditions to meet Process Control Document requirements and mechanical and physical properties
Implementation and operation of mechanical and electromechanical systems
Actively pursue and direct process improvements to improve performance, cost, etc

What we offer

Offers Equity
healthcare
dental
mental health support
parental planning resources
retirement savings options
generous paid time off

Fulltime

Senior Manager Manufacturing Systems Engineering

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Holly Springs

Salary:

148715.15 - 201202.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering
Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus
Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments
Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing
Direct knowledge of integrating various OEM automation software and field instrumentation technologies
In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience with Tech Transfer, Process Design, and Commissioning & Qualification

Job Responsibility

Oversee the Automation Engineering team, lead technical projects, and drive innovation and support manufacturing’s automation needs
Solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives
Provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations
Build and lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function
Support design reviews while partnering closely with the corporate engineering team
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS)
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls
Provide mentoring to develop and accelerate site technical automation capabilities

What we offer

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

Fulltime

Senior Process Engineer I

As a key hire at the Beam North Carolina site (‘Beam NC’), the Senior Process En...

Location

United States , Durham

Salary:

140000.00 - 160000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS in Chemical Engineering, Bioengineering, Biochemistry, or similar with minimum 5 years of relevant work experience, or a M.S. degree with a minimum of 3 years of relevant work experience
Demonstrated technical expertise within autologous cell therapy, mRNA, and/or LNP therapeutics (experience in CGT manufacturing is preferred), downstream processing for production of large molecule biologics, gene therapy
Experience in single-use systems, closed processing, and aseptic manufacturing techniques
Experience successfully leading manufacturing event investigations, Root Cause Analysis (RCA), and Corrective and Preventative Action (CAPA)
Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience
Dynamic interpersonal skills and the ability to manage through influence
Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment
Results oriented with the ability to demonstrate resiliency, ownership, and drive
Must be able to work onsite at our Durham, NC facility

Job Responsibility

Act as subject matter expert for CGT equipment and processes in support of cGMP clinical and commercial manufacturing, with focus on the commercialization of Beam’s autologous cell therapy program
Provide Person-In-Plant (PIP) support to manufacturing, as required
Support facility and equipment design and qualification to meet process and regulatory expectations
Lead or contribute to the creation of technical documentation including project documents, equipment preventive maintenance and calibration procedures, process validation plans/protocols/reports, risk assessments, etc
Support deviation and change control generation, review, and execution
Own and manage small CapEx and process improvement projects for the Beam Engineering and Facilities team, and support larger CapEx projects as the process engineering lead
Supports regulatory reviews and responses, audits and regulatory inspections, as required
Represent the Beam NC Engineering & Facilities team within cross functional project teams as required
Establish and maintain strong relationships cross-functionally within the broader Beam Team
Ensure safety, compliance and sustainability throughout the engineering functions

Fulltime

Director, Validation

As a member of the Validation organization, the Validation Director will lead ph...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science or engineering required
15+ years of progressive leadership of operational validation experience in Pharmaceutical or Biotechnology industry, required
Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC and industry processes and utilities
Experience in successful management of complex technical issues using structured analysis, methodology and articulates clear and concise direction to other operations staff
Strong experience with project and people management, particularly for large validation projects or programs
Experience in Facility, Equipment and Utility or Cleaning validation is a must (preferably in a multi-product CMO facility)
Demonstrate SME level knowledge of process/equipment validation, computer systems, standards and GxP regulations. Strong technical experience in the successful management of complex validation is required
Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively, across multiple sites, managing both local and remote based staff
Advanced understanding of applicable regulatory requirements (FDA, EMA, international regulatory)
Advanced understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing

Job Responsibility

Provide strategic and operational leadership to the Validation function, ensuring continuous, compliant execution of validation activities in alignment with established procedures, schedules, and business objectives
Evaluate process, equipment, and systems validation capabilities across Operations and develop short- and long-term improvement strategies to support corporate and regulatory goals
Guide the strategy for development, execution, review, and approval of all validation documentation, including IQ, OQ, and PQ protocols and reports
Ensure effective oversight of change control, deviations, investigations, and CAPAs related to validation activities
provide leadership in Quality Management System (QMS) integration and inspection readiness
Partner with senior leadership to define and implement validation strategies for new and existing processes, equipment, utilities, and systems, translating strategy into compliant protocols and SOPs
Direct and manage all aseptic and non-aseptic validation activities, including process validation, cleaning validation, sterilization validation, and equipment qualification
Maintain ownership and accountability for the site Master Validation Plan, ensuring alignment with regulatory expectations and business needs
Serve as a primary client and internal stakeholder interface for assigned validation projects, ensuring alignment on scope, timelines, and compliance requirements
Provide strategic leadership for validation-related regulatory inspections and third-party audits, including timely and effective closure of observations and commitments

Fulltime

Senior Director, Commercial Product and Vein-to-Vein Systems Operations

Beam is seeking a highly talented and motivated Senior Directory, Commercial Pro...

Location

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree or the combination of education and business experience required
Minimum 10+ years of Quality Management, System Management or Commercial Product Operations in Cell and Gene Therapy
Experience supporting FDA BLA submission, inspection and commercial launch required
Experience building or maintaining traceability portal for cell or gene therapy required
Experience with Treatment Center Qualification and Activation for cell and gene therapy required
Strong direct cell or gene therapy commercial experience within the last 5 years
Ability to work independently with very limited supervision
Ability to navigate and be successful in a fast-paced, highly matrixed work environment
Detail-oriented, able to assess and assimilate data and communicate objectively
Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations

Job Responsibility

Establish and lead cross‑functional governance for commercial product execution, including clear ownership, escalation pathways, and decision rights
Drive readiness for regulatory inspections and audits related to commercial product operations and patient‑specific execution
Partner with Commercial, Patient Operations, Gene Therapy Operations, Quality, Supply Chain, and IT to ensure aligned and disciplined execution from order to infusion
Define and execute the COI/COC validation strategy, including SOPs, workflows, risk assessments, and control points across the full patient journey
Translate FDA, FACT, AABB, and other regulatory requirements into practical, auditable, end‑to‑end workflows
Own COI‑related deviation investigations with commercial impact, partnering with Quality and Operations to resolve issues and prevent recurrence
Design and lead a commercial exceptions management framework covering incoming apheresis material, manufactured drug product, logistics, scheduling, and site readiness issues
Lead investigations, root‑cause analyses, escalation management, and CAPA development across Commercial Product Operations in partnership with Manufacturing, Supply Chain, Quality, and Patient Operations
Provide clear, timely communication of execution risks, trends, and mitigation plans to senior leadership
Serve as the business and product owner for Beam’s workflow and traceability portal, partnering with IT on design, build, validation, and ongoing enhancements

Fulltime

Manager PQA

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , New Albany

Salary:

118235.00 - 159965.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 3 years of quality experience
OR Bachelor’s degree and 5 years of quality experience
OR Associate’s degree and 10 years quality experience
OR High school diploma / GED and 12 years of quality experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead, coach, and develop Quality staff across assigned areas and shifts
Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards
Review, approve, and oversee key quality systems including: Deviations
CAPAs
Change Controls
Validation documentation
Procedures and batch records
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Ensure production records and test results are accurate, complete, and inspection-ready

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

Fulltime

Senior Staff Test Engineering Lead

The Technical Lead is responsible for the test solution for a next-generation AM...

Location

Singapore , Singapore

Salary:

Not provided

AMD

Expiration Date

Until further notice

Requirements

Strong hands-on experience supporting complex SoC products (e.g., mobile or automotive processing units)
Proven technical leadership across at least one full SoC product lifecycle (pre silicon to production)
Deep expertise in DFT and ATE test methodologies, spanning areas like ATPG Scan, MBIST, Functional, and High‑Speed IO testing across complex SoC environments
Strong experience with Advantest 93k/Teradyne test platforms
Solid understanding of CPU / GPU / SoC architectures with system level interactions as a plus
Strong programming or scripting skills (Python, C/C++, Perl, Java)
Experience with industry EDA tools (Mentor, Synopsys, Cadence) is a plus
Demonstrated ability to act as a technical decision‑maker and mentor within the test organization
Strong communication skills to engage deeply with global, cross‑functional engineering teams
Willingness and capability to take on broader ownership, including mentoring engineers and contributing to long‑term test strategy and team development

Job Responsibility

Define and drive pre silicon test and characterization strategies for complex SoC products
Establish DFT and pattern requirements, and work with Design and Verification teams to ensure test readiness prior to first silicon
Lead first silicon bring up, silicon debug, and characterization execution across PVT corners
Analyze yield, performance distributions, and device failures
lead root cause analysis and drive corrective actions across global teams
Perform circuit sensitivity analysis, interpret findings, and guide deep dive investigations to resolution
Drive innovation in SoC test, debug, DFT, and test methodology, translating ideas into production ready solutions
Own test content optimization to meet product quality and cost targets
Drive yield, test time, and margin improvements from wafer sort through backend test
Partner with manufacturing and quality teams to ensure stable, scalable production

Fulltime

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Senior Manager Manufacturing Programs - Investigations and Process Ownership

Amgen

Location:
United States , Holly Springs

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 06, 2026

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Senior Manager Manufacturing Programs - Investigations and Process Ownership

Amgen

Location:United States , Holly Springs

Category:Manufacturing

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:April 06, 2026

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