Salas O'Brien / Process Plus is a full-service engineering firm that provides Commissioning and Qualification / Validation (C&Q) services to the food, pharmaceutical and biotech industries. ValidationSpecialists develop and execute C&Q protocols (e.g., IQ/OQ/PQ) for these
industries. Protocols may include verification of manufacturing / packaging facilities, process and
packaging equipment, control systems, utilities, and HVAC / environmental conditions. Commissioning is executed to document delivery of a safe, functional system per Good Engineering Practices (GEP) and
qualification is executed to verify conformance to the FDA's current Good Manufacturing Practices
(cGMPs).
ESSENTIAL JOB FUNCTIONS: The responsibilities listed are fundamental to the position and must be
performed successfully to achieve the key performance objectives of the role. Other responsibilities may
be assigned.
• Conduct cGMP Audits, Gap Analysis, and Impact Assessments as required to scope validation
efforts.
• Develop system specifications per GAMP and / or Good Engineering Practices (GEP).
• Develop project Commissioning and Validation Master Plans (CVMP) that describe C&Q scope,
intent, and strategy.
• Interface with Original Equipment Manufacturers (OEM), Construction Managers (CM), and
construction contractors to develop and execute commissioning protocols and checklists.
• Interface with the end user to develop and execute validation protocols (IQ/OQ/PQ). Execution
includes compiling and analyzing qualification / validation data.
• Develop Trace Matrices (TM) to illustrate the relation of system requirements (UR/FS/DS - User
Requirements / Functional Specifications / Design Specifications) and field verifications
(IQ/OQ/PQ).
• Develop Summary Reports (SR) that clearly and concisely summarize C&Q efforts.
• Represent and defend validation results to client auditors and regulatory authorities.
• Lead validationspecialists in the execution of project tasks.
• Perform other related duties as required and / or assigned.
JOB REQUIREMENTS: A Lead ValidationSpecialist (VS-III or VS-IV) is organized, analytical, and self-motivated, possessing considerable knowledge of the food, pharmaceutical, and biotech industries and
FDA regulations.
• A VS-III or VS-IV is expected to manage projects on an administrative and technical level,
including communication with the customer (e.g. status updates for schedule, progress and cost)
• A VS-III or VS-IV is responsible for facilitating the career development of a VS-I or VS-II.
• A VS-III or VS-IV is expected to manage multiple projects of various sizes, simultaneously.
• A VS-III or VS-IV is directly responsible to the Best Practice Lead (VS-III) / Department Manager
(DM) administratively and the Project Manager (PM) for the successful execution of the project.
This job description is intended to describe the general nature, complexity and level of work to be performed by employees assigned to this position and is not construed as an exhaustive list of responsibilities, duties and/or skills required. It does not prescribe or restrict the work that may be assigned and is subject to change at the discretion of the company.
Additionally, a VS-III or VS-IV:
• Must be able to work both independently and as a team leader.
• Must possess the technical aptitude to evaluate engineering documents including specifications,
wiring diagrams, P&ID's, HVAC / mechanical system drawings, and architectural layouts.
• Must possess the technical aptitude and experience necessary to configure and operate portable
measuring instrumentation used to gather verification data.
• Must possess excellent written, verbal and presentation skills.
• Must demonstrate the ability to assess project scope, manage change, and solve problems.
• Must display professional deportment when interfacing with customers, vendors, and trade
contractors.
Education/Experience:
• Bachelor's degree in a scientific, technical, or engineering discipline with 5 to 7 years of
experience working within an FDA regulated environment.
• Associate degree in the same disciplines or skilled technician / military veteran with 7 to 10 years
of experience working within an FDA or other regulated environment.
• Proficiency in Windows & Microsoft Office applications (Word and Excel).
• Proficiency in the use of field measuring instrumentation.
• Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing
Practices (GAMP).
WORKING CONDITIONS:
Working Hours/Environment
• Hours average 40 per week; may require additional hours including evening and weekends
depending on business needs.
• Work performed in an indoor office setting, a client manufacturing facility, and/or a client
construction site.
• Wearing PPE / gowning may occasionally be required.
Travel: Moderate - 40% including the immediate tri-state and regional travel
Physical Demands:
• Ability to work at a computer terminal for extended periods of time.
• Ability to stand and walk for extended periods of time.
• Light lifting up to 20 lbs.
• Ability to speak to and hear employees/clients via phone or in person.
• Body motor skills sufficient to enable incumbent to move around an office environment,
manufacturing environment and construction site.
• Ability to analyze unique situations and develop appropriate response.
$61k-77k yearly est. 31d ago
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Senior Commissioning/Validation Specialist
Stantec Inc. 4.5
Cleveland, OH
Stantec's Buildings team is on a mission to become the world's leading integrated design practice. Our architects, engineers, interior designers, consultants, sustainability specialists, and technologists are passionate about the power of design. Our collaborative culture and our innovative, sustainable approach to projects help us create buildings that matter to our world.
Together, we are enhancing the quality of life globally through design.
Join us and design your place with Stantec.
Your Opportunity
At Stantec our collaborative team partners with clients at all phases of the project lifecycle to bring to life the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the design requirements and produce the expected results. If you are interested in a hands-on role with diverse responsibilities and growth opportunities, we'd be excited to hear from you. We have two immediate openings in our Buildings Commissioning/Validation group for an enthusiastic, diligent and experienced Commissioning / ValidationSpecialist. In this role you will prepare and implements project commissioning/validation plans for existing or new buildings related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify that they are designed, installed, qualified, and capable of being operated and maintained for performance in conformity with specifications, design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/validation, you will work on a variety of projects from small renovations to large complex capital projects across North America.
Your Key Responsibilities
* Perform commissioning/validation tasks including reviewing shop drawings and equipment submittals, reviewing and/or generating commissioning and validation plans, user requirement specifications, functional and design specifications and other applicable lifecycle documents.
* Review designs, drawings, specifications of facility and equipment and automation to understand project scope and commissioning/validation requirements.
* Prepare commissioning/validation protocols adhering to specifications, client templates and lifecycle documents.
* Assist in the execution of commissioning/validation project protocols, including discrepancies, and generating final reports to assist in closure of protocols.
* Assist Director of Commissioning/Validation with client presentations, client contact and communication pertaining to specific project deliverables and business development.
* Coordinate with other Stantec engineering and client disciplines to confirm alignment with the design intent
* Recognize when technical problems are developing and escalate or initiate appropriate corrective actions
* Attend project coordination meetings.
* Support project managers for Commissioning/Validation projects for managing scope and fee for these projects.
Your Capabilities and Credentials
* Good organizational and time management skills
* Must be self-sufficient and self-motivated with strong negotiation skills
* Ability to meet assignment schedule and delivery quality product under pressure
* Strong interpersonal skills
Education and Experience
Bachelor's Degree Engineering with an emphasis in Mechanical, Electrical or Chemical Engineering is preferred, or appropriate combination of relevant education and experience
Minimum of 10 years of related work experience
Travel to our local office and client sites for project work is required
This description is not a comprehensive listing of activities, duties or responsibilities that may be required of the employee and other duties, responsibilities and activities may be assigned or may be changed at any time with or without notice.
About Stantec
Stantec is a global leader in sustainable engineering, architecture, and environmental consulting. The diverse perspectives of our partners and interested parties drive us to think beyond what's previously been done on critical issues like climate change, digital transformation, and future-proofing our cities and infrastructure. We innovate at the intersection of community, creativity, and client relationships to advance communities everywhere, so that together we can redefine what's possible. #DesignYourPlace
Pay Range:
* Locations in VT, & Various CA, NY Areas - Min Salary $ 102,100.00 - Max Salary $ 153,200.00
* Locations in NYC & CA (Bay Area) & NJ (RP) - Min Salary $ 128,600.00 - Max Salary $ 193,000.00
Pay Transparency: In compliance with pay transparency laws, pay ranges are provided for positions in locations where required. Please note, the final agreed upon compensation is based on individual education, qualifications, experience, and work location. At Stantec certain roles are bonus eligible. Actual compensation for part-time roles will be pro-rated based on the agreed number of working hours per week.
Benefits Summary: Regular full-time and part-time employees (working at least 20 hours per week) have access to medical, dental, and vision plans, a wellness program, health saving accounts, flexible spending accounts, 401(k) plan, employee stock purchase program, life and accidental death & dismemberment (AD&D) insurance, short-term/long-term disability plans, emergency travel benefits, tuition reimbursement, professional membership fee coverage and paid family leave. Regular full-time and part-time employees will receive ten paid holidays in each calendar year. In addition, employees will be eligible to accrue vacation between 10 and 20 days per year and eligible for paid sick leave (and if more generous, in accordance with state and local law).
Temporary/casual employees have access to 401(k) plans, employee stock purchase program, and paid leave, in accordance with state and local law.
The benefits information listed above may not apply to union positions because benefits for such positions are governed by applicable collective bargaining agreements
Primary Location: United States | OH | Cleveland
Organization: BC-2808 Buildings-US Northeast BSS
Employee Status: Regular
Travel: Yes
Schedule: Full time
Job Posting: 16/06/2025 05:06:52
Req ID: REQ250001UF
Stantec provides equal employment opportunities to all qualified employees and applicants for future and current employment and prohibit discrimination on the grounds of race, colour, religion, sex, national origin, age, marital status, genetic information, disability, sexual orientation, gender identity or gender expression. We prohibit discrimination in decisions concerning recruitment, hiring, referral, promotion, compensation, fringe benefits, job training, terminations or any other condition of employment. Stantec is in compliance with laws and regulations and ensures equitable opportunities in all aspects of employment. At Stantec we are committed to ensuring our recruitment process is accessible to all. If you require reasonable adjustments to be made during the recruitment process then please inform a member of our Talent Acquisition team.
$65k-85k yearly est. 48d ago
Electro-Mechanical Systems Validation Engineer (Indefinite US Work Authorization Required)
Crown Equipment 4.8
Ohio
:
Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown produces and sells a broad range of forklifts, batteries, chargers, automation and fleet management technologies that are revolutionizing the material-handling industry.
Job Posting External
Job Duties
Provide systems engineering expertise to plan and perform testing and analysis supporting new product development/design verification, manufacturing and supplier quality, and service/warranty analysis for material handling industry.
Test Equipment, Software and Methods - Design and develop special equipment software and methods as required to support assigned projects. Monitor active tests and experiments to ensure validity and quality of the work, perform analysis of results and write formal reports as required.
Laboratory Operations - Support general laboratory operations. Supervise installation, operation and maintenance of specialized test systems and laboratory facilities as assigned.
Planning and Scheduling - Coordinate activities at the work group level, provide technical expertise and detail during project planning; assist Project Validation Engineers, and Engineering Supervisors with creation of project schedule(s).
Technical Staff Supervision - When assigned, provide supervision at the task level to assigned staff. Provide support in area of expertise as required to lab or project staff.
Miscellaneous - Review progress with supervisor. Perform other duties as assigned to include infrastructure projects, budgetary inputs, and procedural documentation.
Work onsite.
Minimum Qualifications
Bachelor degree in Electrical, Mechanical, or Vehicle Systems Engineering, or Computer Science (or Associate degree with 6 years of equivalent experience)
Good verbal and written communication, organizational skills, relevant math, computer, and analytical skills
Ability to safely operate a lift truck
Valid driver license and reliable transportation to travel locally between company locations during scheduled workday
Ability to occasionally travel and overnight stays (0 to 5%)
Ability to occasionally lift 41-50 pounds
Preferred Qualifications
2 or more years related experience including electrical design or systems engineering strongly preferred (Salary will be commensurate with experience)
LabVIEW programming, Data Acquisition (DEWESoft) and Data Analysis (nCode) knowledge
Work Authorization:
Indefinite U.S. work authorized individuals only. Individuals with temporary visas are ineligible. Sponsorship for work authorization, now or in the future, is unavailable.
No agency calls please.
Compensation and Benefits:
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities
$76k-95k yearly est. 60d+ ago
Electro-Mechanical Systems Validation Engineer
Crown Equipment Corporation 4.8
Celina, OH
Electro-Mechanical Systems Validation Engineer (Indefinite US Work Authorization Required) :** Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown produces and sells a broad range of forklifts, batteries, chargers, automation and fleet management technologies that are revolutionizing the material-handling industry.
**Job Posting External**
**Job Duties**
+ Provide systems engineering expertise to plan and perform testing and analysis supporting new product development/design verification, manufacturing and supplier quality, and service/warranty analysis for material handling industry.
+ Test Equipment, Software and Methods - Design and develop special equipment software and methods as required to support assigned projects. Monitor active tests and experiments to ensure validity and quality of the work, perform analysis of results and write formal reports as required.
+ Laboratory Operations - Support general laboratory operations. Supervise installation, operation and maintenance of specialized test systems and laboratory facilities as assigned.
+ Planning and Scheduling - Coordinate activities at the work group level, provide technical expertise and detail during project planning; assist Project Validation Engineers, and Engineering Supervisors with creation of project schedule(s).
+ Technical Staff Supervision - When assigned, provide supervision at the task level to assigned staff. Provide support in area of expertise as required to lab or project staff.
+ Miscellaneous - Review progress with supervisor. Perform other duties as assigned to include infrastructure projects, budgetary inputs, and procedural documentation.
+ Work onsite.
**Minimum Qualifications**
+ Bachelor degree in Electrical, Mechanical, or Vehicle Systems Engineering, or Computer Science (or Associate degree with 6 years of equivalent experience)
+ Good verbal and written communication, organizational skills, relevant math, computer, and analytical skills
+ Ability to safely operate a lift truck
+ Valid driver license and reliable transportation to travel locally between company locations during scheduled workday
+ Ability to occasionally travel and overnight stays (0 to 5%)
+ Ability to occasionally lift 41-50 pounds
**Preferred Qualifications**
+ 2 or more years related experience including electrical design or systems engineering strongly preferred (Salary will be commensurate with experience)
+ LabVIEW programming, Data Acquisition (DEWESoft) and Data Analysis (nCode) knowledge
**Work Authorization:**
Indefinite U.S. work authorized individuals only. Individuals with temporary visas are ineligible. Sponsorship for work authorization, now or in the future, is unavailable.
No agency calls please.
**Compensation and Benefits:**
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities
$75k-94k yearly est. 60d+ ago
Validation Engineer - Driveline and Structural
Crown Equipment Corporation 4.8
Celina, OH
Validation Engineer - Driveline and Structural (Indefinite US Work Authorization Required) :** Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown produces and sells a broad range of forklifts, batteries, chargers, automation and fleet management technologies that are revolutionizing the material-handling industry.
**Job Posting External**
**Job Duties**
+ Test Equipment, Software and Methods - Design and develop special equipment software and methods as required to support assigned projects. Monitor active tests and experiments to ensure validity and quality of the work, perform analysis of results and write formal reports as required.
+ Laboratory Operations - Support general laboratory operations. Supervise installation, operation and maintenance of specialized test systems and laboratory facilities as assigned.
+ Planning and Scheduling - Coordinate activities at the work group level, provide technical expertise and detail during project planning; assist Project Validation Engineers and Engineering Supervisors with creation of project schedules.
+ Technical Staff Supervision - When assigned, provide supervision at the task level to assigned staff. Provide support in area of expertise as required to lab or project staff.
+ Miscellaneous - Review progress with supervisor. Perform other duties as assigned to include infrastructure projects, budgetary inputs, and procedural documentation.
This position works fully onsite.
**Minimum Qualifications**
+ Bachelor degree in Mechanical or Vehicle Systems Engineering, or related degree (Non-degree considered if 12+ years of related experience along with a high school diploma or GED)
+ Good verbal and written communication, organizational, math, computer, and analytical skills
+ Ability to safely operate lift trucks
+ Reliable transportation to travel locally between company locations during scheduled workday
+ Ability to occasionally travel with overnight stays (0-5%)
**Preferred Qualifications**
+ Experience with parametric modeling (SolidWorks or NX)
+ Experience with data acquisition equipment such as Somat or Dewesoft
+ Experience with MTS hydraulic test equipment
**Work Authorization:**
Indefinite U.S. work authorized individuals only. Individuals with temporary visas are ineligible. Sponsorship for work authorization, now or in the future, is unavailable.
No agency calls please.
**Compensation and Benefits:**
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities
$62k-78k yearly est. 60d+ ago
Validation Engineer - Driveline and Structural (Indefinite US Work Authorization Required)
Crown Equipment Corporation 4.8
Celina, OH
: Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown produces and sells a broad range of forklifts, batteries, chargers, automation and fleet management technologies that are revolutionizing the material-handling industry.
Job Posting External
Job Duties
* Test Equipment, Software and Methods - Design and develop special equipment software and methods as required to support assigned projects. Monitor active tests and experiments to ensure validity and quality of the work, perform analysis of results and write formal reports as required.
* Laboratory Operations - Support general laboratory operations. Supervise installation, operation and maintenance of specialized test systems and laboratory facilities as assigned.
* Planning and Scheduling - Coordinate activities at the work group level, provide technical expertise and detail during project planning; assist Project Validation Engineers and Engineering Supervisors with creation of project schedules.
* Technical Staff Supervision - When assigned, provide supervision at the task level to assigned staff. Provide support in area of expertise as required to lab or project staff.
* Miscellaneous - Review progress with supervisor. Perform other duties as assigned to include infrastructure projects, budgetary inputs, and procedural documentation.
This position works fully onsite.
Minimum Qualifications
* Bachelor degree in Mechanical or Vehicle Systems Engineering, or related degree (Non-degree considered if 12+ years of related experience along with a high school diploma or GED)
* Good verbal and written communication, organizational, math, computer, and analytical skills
* Ability to safely operate lift trucks
* Reliable transportation to travel locally between company locations during scheduled workday
* Ability to occasionally travel with overnight stays (0-5%)
Preferred Qualifications
* Experience with parametric modeling (SolidWorks or NX)
* Experience with data acquisition equipment such as Somat or Dewesoft
* Experience with MTS hydraulic test equipment
Work Authorization:
Indefinite U.S. work authorized individuals only. Individuals with temporary visas are ineligible. Sponsorship for work authorization, now or in the future, is unavailable.
No agency calls please.
Compensation and Benefits:
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities
Nearest Major Market: Lima
Nearest Secondary Market: Findlay
Job Segment: Testing, Structural Engineer, Developer, Systems Engineer, Engineer, Technology, Engineering
$62k-78k yearly est. 60d+ ago
Validation Engineer - Driveline and Structural (Indefinite US Work Authorization Required)
Crown Equipment 4.8
Ohio
:
Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown produces and sells a broad range of forklifts, batteries, chargers, automation and fleet management technologies that are revolutionizing the material-handling industry.
Job Posting External
Job Duties
Test Equipment, Software and Methods - Design and develop special equipment software and methods as required to support assigned projects. Monitor active tests and experiments to ensure validity and quality of the work, perform analysis of results and write formal reports as required.
Laboratory Operations - Support general laboratory operations. Supervise installation, operation and maintenance of specialized test systems and laboratory facilities as assigned.
Planning and Scheduling - Coordinate activities at the work group level, provide technical expertise and detail during project planning; assist Project Validation Engineers and Engineering Supervisors with creation of project schedules.
Technical Staff Supervision - When assigned, provide supervision at the task level to assigned staff. Provide support in area of expertise as required to lab or project staff.
Miscellaneous - Review progress with supervisor. Perform other duties as assigned to include infrastructure projects, budgetary inputs, and procedural documentation.
This position works fully onsite.
Minimum Qualifications
Bachelor degree in Mechanical or Vehicle Systems Engineering, or related degree (Non-degree considered if 12+ years of related experience along with a high school diploma or GED)
Good verbal and written communication, organizational, math, computer, and analytical skills
Ability to safely operate lift trucks
Reliable transportation to travel locally between company locations during scheduled workday
Ability to occasionally travel with overnight stays (0-5%)
Preferred Qualifications
Experience with parametric modeling (SolidWorks or NX)
Experience with data acquisition equipment such as Somat or Dewesoft
Experience with MTS hydraulic test equipment
Work Authorization:
Indefinite U.S. work authorized individuals only. Individuals with temporary visas are ineligible. Sponsorship for work authorization, now or in the future, is unavailable.
No agency calls please.
Compensation and Benefits:
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities