Manufacturing Process Coordinator Job at Danaher Corporation (Tauranga)

Specialist Manufacturing: NPI, Upstream Process Owner

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

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

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

Fulltime

Process Engineer, Manufacturing Science & Technology

As we move our cell therapy programs through late-stage development toward BLA s...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

B.S. with 3 + years or M.S. with 2-3 years' experience within biologics process development, MSAT or manufacturing under cGMP processes or PhD degree
Previous experience and working knowledge of T-cells or immunological cell therapies
Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required
Experience supporting late-stage MSAT activities, including process characterization, PPQ planning/execution, scale-up/scale-out strategies, and continued process verification
Direct involvement in BLA-enabling MSAT deliverables such as Module 3 process descriptions, validation packages, tech transfer documentation, and inspection readiness strongly preferred
Good working knowledge in cGMP manufacturing of biological process and ICH regulations
Strong written and verbal communication skills
Highly organized and efficient
Able to work independently
Strong problem-solving skills

Job Responsibility

Support technology transfer of mature, optimized processes to CMOs for clinical and late-phase cGMP manufacturing, ensuring readiness for PPQ and commercial-scale operations
Provide manufacturing oversight at CMOs, including person-in-plant support, review of manufacturing performance, and real-time issue escalation to maintain phase-appropriate control strategies
Execute process development and characterization studies, generate high-quality protocols and reports, and present data to cross-functional teams to inform PPQ planning and BLA Module 3 content
Ensure timely and accurate data capture, supporting data integrity requirements for late-stage filings, validation packages, and regulatory inspections
Maintain all training requirements in a compliant state, aligning with expectations for late-stage manufacturing and inspection readiness
Support phase-appropriate cell therapy processes using QbD principles, including identification of CPPs/CMAs and contributing to control strategy refinement for BLA submission
Identify and evaluate new technologies that enhance scalability, robustness, cost efficiency, and process consistency in preparation for commercial readiness
Provide ongoing oversight of CMO operations, including batch record and testing documentation review, data trending, and deviation/CAPA support consistent with PPQ and late-stage expectations
Coordinate internal and external activities related to patient material and product logistics, ensuring compliant chain-of-identity/chain-of-custody processes critical for pivotal trial operations
Support MSAT planning for development and validation materials, maintaining inventory and coordinating procurement to enable process characterization and PPQ readiness

What we offer

health and retirement, PTO, and stock option plans

Fulltime

Specialist Manufacturing: NPI, Process Owner

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

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

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

Fulltime

Process Technologist

Help develop the manufacturing capability needed to take approved product concep...

Location

United Kingdom , Highbridge

Salary:

Not provided

Bakkavor

Expiration Date

Until further notice

Requirements

Demonstrable experience in a manufacturing environment
Practical understanding of technical, production, or development processes
Project coordination skills
Understanding of critical paths
Ability to deliver outcomes efficiently while managing multiple priorities
Strong organisational skills and diligence
Pragmatic and proactive approach to challenges
Self-driven and results-focused

Job Responsibility

Deliver trials on time and in line with business-critical paths
Prepare and complete transit tests
Review microbiological and nutritional results
Ensure compliance with customer codes and project objectives
Facilitate post-trial evaluation
Conduct food safety validations in line with site CCPs and HACCP principles
Manage raw materials and packaging
Plan and support customer panels
Build stakeholder relationships
Monitor factory processes

What we offer

A Range of voluntary benefits (holiday purchase scheme, additional life assurance, dental & hospital cash plans)
25 days holiday Plus Bank Holidays
Private Medical Insurance (after 5 years’ service)
Life Assurance (1 x salary)
Staff Shop
Stakeholder Pension Scheme
MyBargains Discount Platform
Personal Accident Insurance
Free Independent Mortgage Advice
Employee Assistance Programme

Fulltime

Administrator

Butler Rose is delighted to be partnering with an innovative and fast-growing ma...

Location

United Kingdom , Plymouth

Salary:

28000.00 - 30000.00 GBP / Year

Butler Rose

Expiration Date

Until further notice

Requirements

Previous experience in a manufacturing environment is highly desirable
Strong systems knowledge with the ability to learn new platforms quickly
Excellent communication skills, both written and verbal
Highly organised, with strong attention to detail and the ability to manage multiple tasks simultaneously
Customer-focused with a positive, solution-led attitude
Confident working collaboratively across different departments

Job Responsibility

Order Processing: Accurately load customer orders into internal systems, ensuring all information is complete and correct
Margin Checking: Review and verify margins on orders to support commercial accuracy
Customer Communication: Liaise with customers regarding delivery dates, order updates, and general enquiries, maintaining a professional and friendly approach
Coordination: Work closely with production, logistics, and sales teams to ensure alignment on order priorities and lead times
Documentation: Maintain clear and accurate records, ensuring all documents are filed and accessible
Organisation: Support general administrative tasks, keeping workflows structured and ensuring deadlines are met

What we offer

Competitive salary and stable working hours
Work in a supportive environment where your organisational skills will make a real impact
Join a modern, innovative manufacturer with a strong reputation for quality and growth

Fulltime

Quality Assurance Coordinator

iBUILT is searching for an experienced Quality Assurance Coordinator who can ana...

Location

Salary:

Not provided

iBUILT

Expiration Date

Until further notice

Requirements

Associate degree in applicable field of study
A minimum of 5 years related experience required
Automotive process experience desired
Lean manufacturing experience
Six Sigma experience
DFMA experience and understanding
Use of 8D NCR or similar tool
3 years + in manufacturing preferred
Prolonged periods of standing
Must be able to lift to 25 pounds at a time

Job Responsibility

Develop key performance indicators
Development of business flow process charts
Development of time and process standards
Department policy and procedure outline for operations, safety and environment processes, supply chain management, and compliance identification and conformance training
Define and implement processes and actions to ensure planned LPI’s are met or exceeded in manufacturing
Work on documentation and record retention standards
Quality assurance standards and practices review and inspections
Enforcing and educating on lean manufacturing methods
Assembly and sub-assembly process definition and controls with automation analysis and implementation
Job safety analysis and education as directed by safety management

What we offer

Health insurance
Dental insurance
Vision insurance
Retirement plan
Paid time off

Fulltime

Production Coordinator

Production Coordinator role for an award-winning manufacturing company. You'll b...

Location

United Kingdom , Chelmsford, Essex

Salary:

30000.00 - 35000.00 GBP / Year

Office Angels

Expiration Date

Until further notice

Requirements

Proven experience in project coordination or production planning, ideally within manufacturing
CAD experience required, with the ability to confidently review and interpret technical drawings using AutoCAD to support production planning and coordination
Exceptional organisational skills and a sharp eye for detail
Strong communication skills-able to engage confidently with all levels of the business
Proficiency in project management tools and Microsoft Office Suite
A proactive mindset, positive attitude, and a genuine passion for teamwork and problem-solving

Job Responsibility

Coordinating project timelines, resources, and deliverables to keep production on track
Acting as a central point of communication between internal teams and external stakeholders
Monitoring progress, identifying bottlenecks, and preparing detailed milestone reports
Review and interpret technical drawings using AutoCAD to support project planning and ensure production accuracy
Supporting the creation of project proposals, documentation, and process improvements
Anticipating risks and implementing proactive solutions to keep projects moving forward
Handling administrative tasks that support seamless operations across the production team

What we offer

Make an Impact: Be at the heart of projects that shape the future of production
Collaborative Culture: Join a team that values your ideas, input, and creativity
Career Growth: Access to training, development, and clear progression pathways
Work-Life Balance: Enjoy a supportive environment that prioritises your well-being

Fulltime

Process Manager

Reporting to the Plant Manager, the Process Improvement Manager executes process...

Location

Canada , Hawkesbury

Salary:

Not provided

Biscuits Leclerc Ltd

Expiration Date

Until further notice

Requirements

Bachelor's degree in food science/engineering, chemical engineering or combined equivalence with relevant experience
Over 5 years' experience in a manufacturing environment
Interest in and ability in management
Relevant experience with various “Lean” approaches
Communicates effectively in 2 languages: French and English (spoken and written)
Available to cover different shifts as needed
Available for occasional travel

Job Responsibility

Coordination of improvement projects
Coordinates process improvement projects linked to the plant's strategic plan
Support process leader specialists in project implementation
Facilitates workshops using a DMAIC project management approach
Manages changes brought about by new methods
Operations support
Supports the implementation of new products
Technical expert: Coach operations
Ensures line departures
Participates in various operational meetings

Fulltime

Manufacturing Process Coordinator

Danaher Corporation

Location:
New Zealand , Tauranga

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 21, 2026

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