Engineering Validation Associate Job at BioMarin Pharmaceutical (Cork)

Validation Engineer

We are seeking a skilled Validation Engineer to join our team. The ideal candida...

Location

United States , Ashburn

Salary:

Not provided

IT Minds LLC

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Science, Technology, Engineering, or related field
Minimum 5 years of experience in validation or a related occupation
Strong understanding of FDA regulations and cGMP requirements
Experience with CAPA systems, deviation handling, and audit readiness is preferred
Excellent analytical, documentation, and communication skills

Job Responsibility

Prepare Validation Master Plans and author validation protocols (IQ, OQ, PQ) in accordance with FDA regulations
Execute validation activities and manage associated processes, including change controls, CAPA, and deviation records
Monitor and ensure data integrity
compile and analyze data for summary reports and trend analysis
Support regulatory audits and internal self-inspections
Ensure compliance with applicable Standard Operating Procedures (SOPs) and quality requirements

Fulltime

Senior Associate, Packaging Engineer

Consumer packaging is everywhere and in many cases it’s unavoidable. Packaging ...

Location

United States , New York

Salary:

90800.00 - 113500.00 USD / Year

Harry's

Expiration Date

Until further notice

Requirements

Studied/degree in Packaging Engineering and/or studies in mechanical engineering, industrial design, materials and chemical engineering and related fields. BS in Package Engineering, Mechanical Engineering, other related disciplines, or demonstrated equivalent experience
2+ years of experience in the design, testing, and development of new packaging using a range of component manufacturing processes and materials
Having knowledge of a variety of material properties and packaging components such as pumps, closures, bottles, tubes, aerosols, folding cartons, gift sets, flexible films and laminations
You have a good eye for design and aesthetics, plus experience with decorating techniques and materials used on primary and secondary packaging
Honest, direct, and ability to articulate and defend technical packaging decisions as well as communicate clearly with cross functional teams
Experience with 2D engineering drawings to define critical dimensions, and using engineering analysis methods such as Tolerance Analysis and Statistical Analysis
Experience in one 3D MCAD package (eg. Artios, Solidworks)
Extremely organized, dependable and self-motivated with the ability to excel in a hands-on, fast paced environment
Life-long learner: You love learning new things and are not afraid to admit when you don’t know an answer
Sense of humor -- we take our work seriously and ourselves un-seriously

Job Responsibility

Bring your passion and enthusiasm for package engineering to work every day
Research packaging sustainability/innovation/trends and develop packaging components that support new product introductions, retail exclusives, promotions and partnerships, and operational initiatives
Recommend and own packaging workstreams required to qualify packaging components, tooling, equipment and processes
Develop specifications as part of the package development process. Access, modify or create 3D CAD models and 2D engineering drawings to build prototype tools, samples, and approve component structures
Work with packaging component suppliers to design for manufacturing, apply robust testing plans to validate the design, and qualify production release in partnership with technical cross functional partners
Participate in and drive packaging engineering design reviews
Own packaging line trials and test plans. Troubleshoot packaging-related technical issues during development
develop risk mitigation plans and packaging alternatives
Work with the Production Artist team to develop color standards and establish production color ranges
Bring printing and decorating experience to the process of graphics design, decoration testing, and artwork approval

What we offer

Medical, dental, and vision coverage
401k match
Equity in Mammoth Brands
Flexible time off and working hours
Wellness and L&D stipends
4 weeks sabbatical after 5 years, 6 weeks after 10 years, and 8 weeks after 15 years
20 fully paid weeks off for parents who give birth, or 16 fully paid weeks off for all other paths to parenthood
Fun IRL and virtual events including happy hours, team building events, and parties on our rooftop
Free products from all of our brands

Fulltime

Process Validation Associate

This position reports to the Process Validation Manager and is responsible for m...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
Organizational and management skills to participate in multi-discipline project groups
Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate
Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations
Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations
Proficiency with technical writing expected
Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point

Job Responsibility

Perform process validation activities related to BioMarin’s drug substance and drug products, through defined clinical and commercial stages
Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes
Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits
Development and implementation of SOPs/Guideline documents with systemic procedural improvements
Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures
May participate on sub-teams
Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Participate in multi-departmental meetings & project teams
Identifies and assists with implementation of improvements to Process Validation systems (department level impact)
Generation of process validation master plans, core validation master plans and additional supporting documentation

Fulltime

FLEX Associate Quality Engineer

Temporary entry-level quality engineering role focused on supporting development...

Location

United States , Bethesda

Salary:

44.90 - 74.04 USD / Hour

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Experience in software testing
Undergraduate degree or equivalent experience/certification
Technology certifications
Experience in Agile methodologies

Job Responsibility

Collaborates with product team members on QE tasks and procedures
Functions as a working SDET where needed
Assists in setting best practice quality procedures
Reviews and edits product documentation
Drives the adoption of TDD, BDD and related test-first development methodologies
Performs quantitative and qualitative analyses for delivering automated testing processes and tools
Implements tooling such as Tosca, NeoLoad, Cucumber, etc.
Validates solutions with enterprise architecture team
Facilitates achievement of expected deliverables and obligations of Service Providers
Ensures proper coordination with appropriate IT and vendor teams

What we offer

Medical coverage
Dental coverage
Vision coverage
Health care flexible spending account
Dependent care flexible spending account
Life insurance
Disability insurance
Accident insurance
Adoption expense reimbursements
Paid parental leave

Fulltime

Computer Systems Validation Engineer

Understand and analyze requirements, define tasks and execute them. Involve in p...

Location

United States , Piscataway, NJ and various unanticipated locations throughout the U.S.

Salary:

Not provided

National Computer Systems

Expiration Date

Until further notice

Requirements

CAPA
CGXP
GAMP
HP ALM
CSV
21 CFR
Audit Trial
Agile
GAP Analysis
Service Now

Job Responsibility

Understand and analyze requirements, define tasks and execute them
Involve in preparing documentation for all aspects of the computer system validation life cycle
Design, deliver, support and maintain GxP computerized systems and security of the associated data
Create and review validation plans, user requirement specifications, functional/design specifications, system integration and user acceptance test design and traceability matrix
Validate models for risk management and compliance
Coordinate with offshore team in an onsite-offshore model

What we offer

Referring employee will be eligible to receive an award of $1,000.00 for the successful referral

Associate R&D Test Engineer

Silvus is seeking a full-time Associate R&D Test Engineer to report to the R&D D...

Location

United States , Los Angeles

Salary:

70000.00 - 85000.00 USD / Year

Silvus Technologies (International)

Expiration Date

Until further notice

Requirements

High School Diploma or GED with 3 years of experience in electronics work environment
Associate degree with 1 year of experience
Bachelor or higher degree from an accredited university or college
Familiarity and experience working in testing embedded systems
Exposure to the use of RF instruments such as signal generators, spectrum analyzers, and channel emulators
Must be a U.S. Person (permanent resident or citizen)
Must be able to lift up to 50 lbs.
Must be able to perform bending, reaching, kneeling, squatting, walking/moving

Job Responsibility

Wireless communication system test operation, implementation, and maintenance
Assist in the maintenance, design, and implementation of testing software for automated testing and logging
Work closely with the rest of the R&D and Engineering teams to understand performance requirements and expected system behaviors, validate and assist in troubleshooting and qualification of new designs
Conduct lab testing using wireless channel emulators and other instruments
Conduct field testing to qualify system performance in a practical environment
Occasional domestic travel to support experimentation and demonstration

What we offer

Reasonable accommodation for individuals with disabilities

Fulltime

Manufacturing Engineering Technician

As a member of the Manufacturing Engineering team, the Engineering Technician wi...

Location

United States , Manchester

Salary:

24.00 - 25.00 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Associates Degree in Engineering, Mechatronics or other technical field
1+ years’ experience in technical, hands-on problem solving role in a highly regulated environment, medical preferred
Demonstrated, hands-on skills with electrical, mechanical, pneumatic or hardware troubleshooting
Knowledge and ability to read blueprints, drawings
Experience with Lean and/or structured problem solving tools
Demonstrated skills to provide basic data analysis and reporting
Demonstrated skills with MS Office applications
Superior verbal and written communication skills
Excellent interpersonal skills
Ability to manage multiple priorities daily

Job Responsibility

Provide direct technical support to the Production Operations and Manufacturing Engineering teams within daily business operations
Act as accountable technical team member for process yield performance for a limited production area
Provide hands-on technical support to operations for manufacturing issues directly within a clean-room environment
Support and facilitate productivity and throughput improvement projects to achieve target process run rates
Perform hands-on failure analysis and investigation to process nonconformities
Report-out to production line team on details of technical investigation through clear, thorough and specific documented feedback
Work with engineering team resources to develop and implement process improvement projects
Design, develop and fabricate simple manufacturing tools, fixtures and devices
Collaborate with vendors, suppliers and other company team members for engineering projects
Support the execution of change-management process elements including validation documentation, process work instructions, engineering studies and other technical writing

Fulltime

Manufacturing Engineering Technician

As a member of the Manufacturing Engineering team, the Engineering Technician wi...

Location

United States , Manchester

Salary:

24.00 - 25.00 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Associates Degree in Engineering, Mechatronics or other technical field
1+ years’ experience in technical, hands-on problem solving role in a highly regulated environment, medical preferred
Demonstrated, hands-on skills with electrical, mechanical, pneumatic or hardware troubleshooting
Knowledge and ability to read blueprints, drawings
Experience with Lean and/or structured problem solving tools
Demonstrated skills to provide basic data analysis and reporting
Demonstrated skills with MS Office applications
Superior verbal and written communication skills
Excellent interpersonal skills
Ability to manage multiple priorities daily

Job Responsibility

Act as accountable technical team member for process yield performance for a limited production area
Provide hands-on technical support to operations for manufacturing issues directly within a clean-room environment
Support and facilitate productivity and throughput improvement projects to achieve target process run rates
Perform hands-on failure analysis and investigation to process nonconformities
Report-out to production line team on details of technical investigation through clear, thorough and specific documented feedback
Work with engineering team resources to develop and implement process improvement projects
Design, develop and fabricate simple manufacturing tools, fixtures and devices
Collaborate with vendors, suppliers and other company team members for engineering projects
Support the execution of change-management process elements including validation documentation, process work instructions, engineering studies and other technical writing

Fulltime

Engineering Validation Associate

BioMarin Pharmaceutical

Location:
Ireland , Cork

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Requirements:

Additional Information:

Job Posted:
January 07, 2026

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Requirements:

Additional Information:

Job Posted:January 07, 2026

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Job Posted:
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