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 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, Financial Control

We are seeking a highly motivated Accounting Manager to join our growing account...

Location

United States

Salary:

95000.00 - 130000.00 USD / Year

RemotivateJobs

Expiration Date

Until further notice

Requirements

Bachelor’s degree in accounting or finance
3+ years experience in accounting
Advanced Excel/Google Sheets skills
Hands-on experience with accounting software packages, like NetSuite
GAAP/IFRS or equivalent accrual-based accounting knowledge
Attention to detail and ability to analyze number discrepancies
Experience with month-end close, consolidations in a multiple currency environment, including recording intercompany transactions
Direct experience in revenue recognition across various revenue streams
Capable of investigating and resolving accounting discrepancies
Experience with system implementations

Job Responsibility

Plan and oversee all accounting tasks in support of operations, including accounts payable, accounts receivable, cash management, and general ledger for one of our 3 service lines
Lead all month-end close and general ledger reconciliation processes pertaining to that specific service line
Assist in managing accounts receivable and accounts payable processes for various DEPT® US entities within the service line through standardization of process and optimization of internal controls to focus on working capital management and cash flow optimization
Manage various treasury management workflows, including cash tracking, management, and cash forecasting for various DEPT® US entities within the service line
Partner with senior management on the preparation of budgets and forecasts and develop accurate and timely reports on actuals vs budgets
Comply with local, state, and federal government reporting requirements and tax filings
Review financial statements and trend analysis to ensure proper reporting and understanding of the business
Partner closely with FP&A and Group Financial Reporting teams around monthly variance analysis and management reporting
Coordinate the provision of information to external auditors for the audits
Assist the DEPT® US accounting team with monthly/quarterly deliverables

What we offer

Healthcare, Dental, and Vision coverage
401k plan, plus matching
PTO
Paid Company Holidays
Parental Leave

Fulltime

Accountant

We are looking for a detail-oriented Accountant to join our client's team in Day...

Location

United States , Dayton

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Minimum of 1 year of accounting experience, preferably in manufacturing
Proficiency in handling sales tax and tax compliance
Strong knowledge of general ledger management and journal entries
Experience in month-end and year-end financial closings
Familiarity with balance sheet preparation and analysis
Ability to perform bank reconciliations accurately and efficiently
Understanding of audit processes and documentation requirements
Excellent attention to detail and analytical skills

Job Responsibility

Prepare and file state tax documents in compliance with regulations
Perform accurate bank reconciliations to ensure proper accounting of transactions
Maintain and update the general ledger with accurate financial entries
Analyze and verify balance sheets to ensure data integrity
Assist in the month-end and year-end closing processes, including the preparation of financial statements
Support internal and external audits by providing necessary documentation and analysis
Create and post journal entries to reflect accurate financial activity
Collaborate with team members to address discrepancies and improve accounting processes
Monitor financial data to identify trends and areas for improvement

What we offer

medical
vision
dental
life and disability insurance
eligibility to enroll in company 401(k) plan

Guest Service Agent

Four Points by Sheraton - where timeless classics are integrated with modern det...

Location

Australia , Sydney

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Experience with OPERA property management system or similar
Relevant experience in a similar role
Working rights in Australia
Enthusiastic to escalate your career
Self-motivated, driven and energized in a fast-paced environment
Armed with smart solutions and a can-do attitude

Job Responsibility

Assist travellers arriving and departing the hotel through the check in and departure process
Handle general enquiries, and provide a friendly, genuine service with each traveller experience
Build and strengthen relationships with existing and new travellers to enable future bookings
Support your front office team in general operational tasks
Take guest reservations and perform cash handling & credit card responsibilities
Be an expert on the hotel and the surrounding area, have a sense of the local to exceed guest expectations

What we offer

Exclusive staff discounts on food and beverage and hotel rooms (including all properties within the Marriott International group) for you, your family and friends
Be part of Life with the Works program where you can enjoy flexible working hours & locations, time off to pursue your passion through sabbatical leave, and paid leave during your birthday month
Grow, develop, and progress with internationally recognised training programs, unlimited strategic development and exciting career opportunities within the Marriott International group
Genuine care for associates’ physical, emotional and financial wellbeing through our Employee Assistance Program
Opportunity to receive Employee Referral Incentives and get paid for working with your friend
Work for the Largest Hotel Network in the World which values equality, diversity and inclusiveness

Parttime

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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