Process Validation Engineer Job at MillenniumSoft Inc (Warwick)

Process Engineer – Engineering Support

We are looking for a multiple Engineering resources to join our Life Sciences te...

Location

United States

Salary:

Not provided

AM Technical Solutions

Expiration Date

Until further notice

Requirements

2+ years’ of experience working within a GMP or highly regulated engineering environment
Ability to work independently on projects with applicable client stakeholders in Validation, Quality, Manufacturing, Maintenance, and other relevant personnel
Strongly motivated, well-organized, and shows professional initiative
Takes ownership of assignments, can work both independently and as part of the team
Ability to work in a fast-paced and challenging environment
Excellent organization skills with the ability to manage multiple tasks simultaneously
Bachelors Degree in Mechanical or Chemical Engineering or related field experience

Job Responsibility

Operational support for GMP manufacturing sites
Supporting/troubleshooting equipment
Ownership of small projects and quality systems
Familiarity of Manufacturing Systems Lifecycle approach
Must be familiar with CAPAs, deviations, and change control protocols

Process Engineer

Automate and continuously improve production processes to ensure maximum efficie...

Location

Morocco , Tangier

Salary:

Not provided

DOGA USA, Corp.

Expiration Date

Until further notice

Requirements

Degree in Mechanical, Industrial or similar Engineering
2–4 years in process design and continuous improvement in an industrial environment
Fluent in English or Spanish
Knowledge of process FMEA
Advanced level of SolidWorks for design and interpretation

Job Responsibility

Analyze and implement improvements in production lines to increase performance and process efficiency
Troubleshoot plant line issues to ensure products are manufactured according to customer specifications
Lead the industrialization of new products, including process documentation and validation
Optimize workstation layouts and line designs for better ergonomics and productivity
Collaborate with external plants and workshops for the industrialization of new components and plant reorganizations
Participate in departmental and interdepartmental meetings to coordinate plant needs

What we offer

Join a Thriving Company: Work for a rapidly growing and strategically positioned company
Dynamic Team Environment: Collaborate in active work environment alongside a team of highly qualified and dedicated professionals
Inclusive Culture: Thrive in an inclusive culture that values diversity, where all individuals, regardless of background, gender, sexual orientation, abilities, or gender identity, feel respected and valued

Process Engineer

The Process Engineer plays a critical role in ensuring the safety of employees, ...

Location

United States , Salt Lake City

Salary:

100000.00 USD / Year

Hunter Douglas

Expiration Date

Until further notice

Requirements

Engineering degree or equivalent
At least 3 years of experience in process engineering/industrial engineering (5 years preferred)
At least 1 year of experience in a project management role within the manufacturing industry
Strong analytical and problem-solving skills
Effective communication
Proficient planning and organizational skills
Ability to manage multiple tasks and projects simultaneously
High attention to detail
Results-oriented mindset
Willingness to travel (20%+)

Job Responsibility

Guide projects, tasks, and design direction by identifying areas of opportunity through process engineering principles
Coordinate multiple small to medium-sized projects concurrently, ensuring timely completion within budget
Lead continuous improvement initiatives and capex projects
Perform safety process walks and implement effective countermeasures to identify risks and ensure zero accidents
Develop and maintain standard work procedures to achieve targeted efficiency, including packaging
Define and maintain cycle times for each operation and document them monthly
Lead multidisciplinary teams to achieve process target efficiencies and support flawless implementation of new processes
Conduct weekly process/Gemba walks to ensure compliance with standard work and guidelines, identify opportunities, and implement countermeasures
Validate and approve packaging design, specifications, and appearance for new packaging or equipment/tooling
All other duties as assigned

What we offer

Bonus target range: 15%
Generous benefits package including medical, dental, vision, life, disability
A company culture that prioritizes internal development and professional growth
Time off with pay
401(k) plan with a degree of employer matching
Paid parental leave
Wellness programs and product discounts

Fulltime

Mechanical Process Engineer III

The Process Engineer plays a critical role in ensuring the safety, quality, and ...

Location

United States , Broomfield

Salary:

95000.00 - 110000.00 USD / Year

Hunter Douglas

Expiration Date

Until further notice

Requirements

Engineering degree or equivalent
Minimum 3 years of experience in process engineering (5 years preferred)
At least 1 year of leadership experience in the manufacturing industry
Project management experience is desirable
Strong analytical and problem-solving skills
Excellent communication skills across all levels
Effective planning and organizational skills
Ability to work independently and manage multiple tasks/projects simultaneously
Results-oriented with high attention to detail
Must be comfortable working from the office for 5 days a week

Job Responsibility

Guide projects and tasks by identifying opportunities through engineering principles to support informed decision-making
Demonstrate independent judgment to adapt methods for non-routine assignments
Coordinate multiple small to medium-sized projects concurrently, assigning tasks and ensuring timely completion
Perform safety process walks, implement countermeasures, and ensure zero accidents due to process issues
Define and document direct labor requirements and cycle times for each process monthly
Lead multidisciplinary teams to achieve process target efficiencies and maintain standard work procedures
Support Level 1 (LV1) process performance, documenting results such as headcount, cycle times, rates, and efficiencies
Develop and maintain Process Failure Mode and Effects Analyses (PFMEAs) to prevent poor quality costs
Conduct weekly process/Gemba walks to ensure compliance with standard work and identify opportunities for improvement
Validate and approve packaging designs and lead packaging trials in collaboration with the Packaging CoE

What we offer

Bonus target range: 20%
Medical, dental, vision plan, life, STD, LTD, AD&D, dependent life, flexible spending
A company culture that prioritizes internal development and professional growth including tuition assistance
Time off with pay that accrues immediately, 11 paid holidays
401(k) with 6% company match and annual retirement contribution
Employee assistance program
Wellness programs

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

Apu Process Engineer - Automation

The APU Process Engineer position is responsible for maximizing effectiveness by...

Location

United States , Buffalo Grove, Illinois

Salary:

80000.00 - 120000.00 USD / Year

Nemera

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Engineering preferred
5+ years of experience, preffered experience in Manufacturing with vision systems, assembly automation equipment
Experience with Plastic Injection Molding and high speed automation equipment preferred
Strong math, reading, and communication skills required
Computer skills, including Microsoft Office applications required
Ability to lift 50 lbs, and stand/walk up to 90% of shift
Able to bend, stoop, reach, push, pull, grab and climb as needed

Job Responsibility

Develops competencies of the production unit through internal and external training and development as needed
Define and update standard operating procedures (SOP) for production employees
Assess and trains setters
Reports outcomes to the APU Shift leader
Support APU Shift leader and managers in analyzing shop floor issues and point of escalation
Propose technical solutions to improve production processes and identifies opportunities to reduce cost, lead-time, and inventory
Analyze equipment’s performance indicators, define and facilitate corrective actions implementation (e.g.: CAPA)
Know, apply, and facilitate implementation of rules defined as part of Continuous Improvement of the plant and its team (5S, TPM, SMED, VSM, etc)
Facilitate workgroups linked to continuous improvement and propose action plans
Accountable of APU equipment’s improvement

Fulltime

Process Engineering Technician

Nemera is a world leader in the design, development, and manufacturing of drug d...

Location

United States , Buffalo Grove

Salary:

Not provided

Nemera

Expiration Date

Until further notice

Requirements

Minimum of 3 years performing tasks as Operator Technician III or equivalent title (pull/set molds, load processes and start/stop presses)
Skills in troubleshooting loading equipment, dryers and other equipment
Forklift driving certification
Able to frequently lift up to 40 lbs.
Ability to push and pull items
Ability to stand and/or walk up constantly during the shift
Ability to climb up and down ladders

Job Responsibility

Support the development of new injection molds by participating in process validation activities
Perform the set-up and removal of injection molding systems
Perform the duties associated with cleaning the material blending, drying and loading systems
Perform line clearance activities per Nemera guidelines
Participate in the optimization activities for injection molding process and robust process window development based on sound process engineering principles
Perform all tasks associated with LRP folder activities
Properly execute BMS activities involving loading and closing sample orders
Ensure that sample runs are performed according to Sample Request (SR) requirements
Perform and document OQ and PQ activities as assigned
Identify system safety hazards and work with site EH&S representatives to remediate appropriately (ex. warning labels, guarding, training, etc.)

Fulltime

Serdes Systems Validation Engineer

We are looking for a talented Senior System Validation Engineer to join a global...

Location

United Kingdom , Hampshire

Salary:

60000.00 - 70000.00 GBP / Year

BLUESTREAM PEOPLE

Expiration Date

Until further notice

Requirements

MSc or BSc in Electrical Engineering
Strong commercial experience in system validation of complex HW/SW/embedded designs
Strong RF physical layer testing skills, with hands-on use of lab equipment
Proficient in automation and programming (Python, C#, C++)
Knowledge of IP networking systems and communication protocols
Experienced in planning and executing system tests, using tools like JIRA/Confluence
Self-motivated, adaptable, and a strong team player with excellent communication skills

Job Responsibility

Lead system validation activities across PHY, hardware, and software
Design, execute, and automate test plans and procedures
Build and manage test setups for regression and manual testing
Perform system integration, bring-up, and debugging
Record, analyse, and investigate defects, identifying root causes and corrective actions
Support continuous integration and test management tools
Analyse and process data, providing clear reporting and metrics

What we offer

Negotiable for the right experience

Fulltime

Process Validation Engineer

MillenniumSoft Inc

Location:
United States , Warwick

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:January 11, 2026

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Job Posted:
January 11, 2026