Top 25618 Process engineering tech Jobs

Risk Assessment / Technical Document Spec.(GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148
TechData Service Company, LLC —Lexington, MA
- $60 - $100 an hour
- Temporary
- Hybrid work
- Microsoft Excel
- Engineering
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
1h
Process Documentation Engineering Technician
Accutron, Inc —Windsor, CT
- $50,000 - $70,000 a year
- Full-time
- Background check
- Computer Science
- English
- Health savings account
- Health insurance
Quick Apply
9d
Engineering/Manufacturing Technician
Kelly Services —Austin, TX
- $21 - $26 an hour
- Overtime
- Ability to walk for extended periods
- Mid-level
- Continuous improvement
- Paid holidays
- Disability insurance
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External Imaging Engineering Tech
TTM Technologies —Stafford, CT
- Overtime
- Microsoft Word
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- Microsoft Outlook
- Health savings account
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1007 Clarios, LLC —Canby, OR
- Full-time
- Engineering
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- Electrical Engineering
- Disability insurance
- Health insurance
Process Engineering Tech I
GITI TIRE USA LTD —Richburg, SC
- Office
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- Ability to lift 75 pounds
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SubCom —Newington, NH
- Full-time
- Bachelor of Science
- Mid-level
- Analysis skills
- Paid parental leave
- Health savings account
Quick Apply
Process Engineering Tech
Merck KGaA —Carlsbad, CA
- $32 - $49 an hour
- Microsoft Excel
- Engineering
- Mid-level
- Health insurance
- Paid time off
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Process Engineering Tech-Quantum
All Flex Solutions, Inc —Minneapolis, MN
- $30 - $35 an hour
- Mid-level
- Experience equivalent to degree accepted
- Communication skills
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- Health savings account
Quick Apply
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Quanta Manufacturing Nashville —La Vergne, TN
- Full-time
- Microsoft Access
- Mid-level
- Windows
Quick Apply
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Parker Hannifin Corporation —Mason, MI
- Overtime
- Carpentry
- English
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- Flexible schedule
Foundry Quality Tech.
Alliant Castings —Winona, MN
- $19 - $26 an hour
- Full-time
- Computer literacy
- Office
- 3 years
- Health savings account
- Health insurance
Quick Apply
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Advanced Solutions & Controls LLC —Miamisburg, OH
- $75,000 - $105,000 a year
- Full-time
- Hybrid work
- System design
- Mid-level
- US work authorization
- Health insurance
- Dental insurance
Quick Apply
Engineering Technician
Enerpac Tool Group —Antigo, WI
- From $26.59 an hour
- Full-time
- Oracle
- Microsoft Outlook
- Word processing
- Health savings account
- Health insurance
Quick Apply
8d
Automation Technician
Cooper Standard —Boiling Springs, SC
- From $30 an hour
- Overnight shift
- Background check
- Mid-level
- Travel
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- Health insurance
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7d
Process Tech - Injection Molding
Forte Products —Burlington, KS
- Online Application
- 5 years
- Mid-level
- Assembly
- Health savings account
- Paid holidays
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DSC Dredge —Reserve, LA
- Overtime
- 18 years or older
- 5 years
- Pass drug screening
- Health insurance
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Engineering Technician
Confidential —Monroe, NC
- $58,000 - $68,000 a year
- Full-time
- Background check
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- Mid-level
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Plastics Engineering Project Manager
Tech NH, Inc. —Merrimack, NH
- $90,000 - $110,000 a year
- Full-time
- Background check
- 5 years
- Bachelor of Science
- Health insurance
- Dental insurance
Quick Apply
Field Superintendent – Instrumentation & Electrical
Canadian Breaks Consulting, LLC —Childress, TX
- $140,000 - $185,000 a year
- Extended hours
- Construction site
- English
- Ability to climb stairs
- Health insurance
- Dental insurance
Quick Apply

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Risk Assessment / Technical Document Spec.(GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148

TechData Service Company, LLC -
Lexington, MA

Quick Apply

Job Details

Temporary | Full-time
$60 - $100 an hour
1 hour ago

Benefits

Health insurance
Dental insurance

Qualifications

Data integrity assurance
Sourcing
Teamwork
Microsoft Excel
Content creation for technical audiences
GxP
Compliance audits & assessments
Visio
Good documentation practices (GDP)
Data quality management
Bachelor's degree
Pharmaceutical company experience
Organizational skills
Contracts
IT
Productivity software
Technical writing experience within technology
Cross-functional collaboration
Standard operating procedures (SOPs)
Bachelor of Arts
Project stakeholder communication
Cross-functional communication
Standard operating procedures drafting
SDLC

Full Job Description

Risk Assessment / Technical Document Specialist (GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148

BB10148

Lexington, MA

12+ Months

This role will serve as a SME across both IT systems and data integrity, ensuring solutions are compliant, inspection-ready, and operationally efficient.

12 Month contract with potential to extend

Onsite Expectations:
For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.

Primary Duties

This contractor role is responsible for modernizing technical system documentation across Quality Control Lab Systems and performing structured data integrity risk assessments to enable risk-based optimization of procedural controls.

The consultant will partner cross-functionally with Quality, IT, and Business Process Owners to:

· Simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates

· Apply Client global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access management

· Provide recommendations to optimize the frequency and design of controls

Responsibilities

1. Technical Documentation Modernization (~50%)

· Assess current-state system documentation across QC GxP systems

· Redesign and standardize documentation structure aligned to SDLC and validation expectations (e.g., FRS, SDCS, SOPs) and global templates

· Ensure documentation aligns with:

o 21 CFR Part 11

o Data integrity expectations

o Internal validation, SDLC and QMS standards

· Partner with system owners and SMEs to validate accuracy and usability of modernized documents

· Identify opportunities to digitize, automate, or rationalize documentation and lifecycle processes in collaboration with QC IT team

2. Data Integrity Risk Assessments & Control Strategy Optimization (~50%)

· Facilitate and execute structured risk assessments using QRM principles (e.g., ICH Q9 methodologies)

· Evaluate data integrity risks across system processes, including:

o Administrative Audit trail Reviews

o User access and privileges

o Data backup and restore

· Assess the effectiveness, redundancy, and burden of existing controls

· Develop risk-based recommendations for:

o Adjusting frequency of audit trail reviews

o Optimizing backup/restore verification approaches

o Rationalizing user account management processes

· Document risk assessments with clear:

o Risk statements

o Impact/severity scoring

o Detectability and mitigation strategies

· Support development of remediation or optimization plans based on findings

· Align outputs with site DI program expectations and governance forums

Education and Experience Requirements

Education

· Bachelor’s degree in Science, Engineering, Information Technology, or related field (required)

Experience

· Experience in GxP-regulated pharmaceutical or biotech environments (required)

· Demonstrated experience with:

o Technical system documentation (FRS, SDCS, SOPs)

o Computerized Systems Validation (CSV) and system lifecycle management

· Experience leading or facilitating Quality Risk Management activities (preferred)

· Strong understanding of data integrity principles and regulatory expectations (required)

· Experience performing data integrity assessments or remediation activities (preferred)

· Experience working cross-functionally in a matrixed organization

Key Skills, Abilities, and Competencies

· Strong knowledge of:

o Data integrity regulations and expectations (ALCOA+, Part 11)

o Risk-based decision making and QRM methodologies

· Ability to translate complex technical systems into simplified, user-friendly documentation

· Expertise in evaluating system controls (audit trails, access, backups, interfaces)

· Strong facilitation skills for risk assessments and cross-functional workshops

· Analytical thinking with ability to challenge legacy practices and drive simplification

· Effective communication skills across technical and non-technical stakeholders

· Ability to operate independently with minimal oversight in a fast-paced environment

Complexity and Problem Solving

· Applies risk-based judgment to evaluate compliance vs. operational efficiency trade-offs

· Makes recommendations that may significantly change control strategies or reduce operational burden

· Balances regulatory expectations with pragmatic, scalable solutions

· Works across multiple systems, functions, and stakeholders simultaneously

Other Job Requirements

· Role role requires on-site presence for workshops, risk assessments, and stakeholder engagement

· Strong proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio)

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Full-time, Temporary

Pay: $60.00 - $100.00 per hour

Benefits:

Dental insurance
Health insurance

Application Question(s):

What City/State are you currently located in?
What hourly rate are you seeking?

Education:

Bachelor's (Required)

Experience:

Control Strategy Optimization: 1 year (Preferred)
Risk-Based Decision Making: 1 year (Preferred)
QRM Methodologies: 1 year (Preferred)
ALCOA+: 1 year (Preferred)
GxP Regulated Pharmaceutical /Bio-Tech Industry: 2 years (Required)
Risk Assessment: 1 year (Preferred)
Technical System Documentation: 3 years (Required)
IT Data Integrity: 3 years (Required)
IT Systems: 3 years (Required)
QC GxP systems: 1 year (Required)
Validations: 1 year (Required)
SDLC: 1 year (Required)

Work Location: Hybrid remote in Lexington, MA 02420

Quick Apply

Refine Your Search

process engineering tech jobs

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