- 5 -7 years of relevant validation engineer experience
- BA/BS in Engineering or Life Sciences
- Expert in current validation requirements and FDA expectations of facility, equipment, and computer validation.
- Establish and maintain good relationships with various site functional groups as well as external validation contractors and consultants.
- Ability to manage and track validation progress in required detail with data basis and schedules.
- Excellent teamwork skills communication and problem-solving skills
- Good communication
- Lead or support cleaning, equipment, utilities, sterilization, and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR), or routine re-qualification activities.
- Ensure the timely completion of Cleaning Monitoring as well as validation team assignments.
- Any deviations, anomalies, or schedule-impacting items are to be reported to site management.
- This position provides trained technical resources for the development and execution of validation protocols by OCN and global procedures. The person will maintain up-to-date training status in the Cornerstone (or equivalent) system.
- Author and review qualification protocols, engineering change orders, SOP changes, Engineering commissioning, and turnover packages. Approval support of any qualification protocols will require approval of the site Validation as well as Quality
- Review Planned/Unplanned events and provide an initial assessment for validation lead.
- Review of lifecycle documents for migration into the new electronic system as well as for additional changes for MAR and tech transfer.
- Responsible for on-time completion of validation activities according to the overall current manufacturing schedule.
- Ensure coordination of Validation requirements with Quality, Manufacturing & Engineering.
- Ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Foster a positive safety culture in which no one gets hurt.
- This position provides resources for the controlled collection, assessment, and reporting of scientific validation or study data in support of validation of processes. The data will be analyzed using algebraic and/or statistical methods to verify adherence to predetermined and approved process criteria. Reports will be written to communicate the outcome of the studies and/or validations.
- This position will provide sampling and inspection support for process equipment as part of the validation execution process. As such, the person must be trained on sampling and inspection procedures; and may be called upon to provide training for others as needed.
- Work in a standard office environment.
- May on occasion work in a clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water, and air together this creates a load environment.
- Maybe exposed to hazardous materials.
- Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management
-
Validation Engineer
5 days ago
BEPC Incorporated Oceanside, United StatesBEPC has an open position for a Validation Engineer III in Oceanside, CA · Contract W2 Period: 8-month contract with possibilities for extensions. · Pay & Benefits: $68-$77/hr. + Medical, Dental, Vision and Life Insurance · Lead or support cleaning, equipment, utilities, steri ...
-
Validation Engineer
6 days ago
BEPC Incorporated Oceanside, United StatesBEPC has an open position for a Validation Engineer III in Oceanside, CA · Contract W2 Period: 8-month contract with possibilities for extensions. · Pay & Benefits: $68-$77/hr. + Medical, Dental, Vision and Life Insurance · Lead or support cleaning, equipment, utilities, steriliz ...
-
Validation Engineer
4 days ago
PSC Biotech Carlsbad, United StatesJob Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...
-
Senior Validation Engineer
13 hours ago
The Fountain Group Oceanside, United StatesThe Senior Validation Engineer plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. This position is onsite in Oceanside, CA. · Duties: · Lead or support cleaning, equipment, utilities, ster ...
-
Senior Validation Engineer
4 days ago
The Fountain Group Oceanside, United StatesThe Senior Validation Engineer plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. This position is onsite in Oceanside, CA. · Duties: · Lead or support cleaning, equipment, utilities, ste ...
-
Senior Validation Engineer
5 days ago
The Fountain Group Oceanside, United StatesThe Senior Validation Engineer plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. This position is onsite in Oceanside, CA. · Duties: · Lead or support cleaning, equipment, utilities, ster ...
-
Senior Validation Engineer
5 days ago
TalentBurst Oceanside, United StatesTitle: Validation Engineer III, Req#: ROCGJP · Location: Oceanside, CA (100% onsite) · Duration: 8+ months Contract · Job Description: · A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or med ...
-
Validation Engineer III
5 days ago
WillHire Oceanside, United StatesA Validation Engineer plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. This position is onsite in Oceanside. Assignment will go through the end of the year · • Lead or support cleaning, ...
-
VTI Life Sciences Oceanside, United StatesVTI Life Sciences (VTI) · is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought l ...
-
5890 Validation Engineer lll
5 days ago
Harvest Technical Services Oceanside, United StatesOnsite: Oceanside, CA · Description: · A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. · Lead or support cleaning, equipment, utilities, sterilization and/or au ...
-
5890 Validation Engineer lll
1 week ago
Harvest Technical Services Oceanside, United StatesOnsite: Oceanside, CA · Description: · A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. · Lead or support cleaning, equipment, utilities, sterilization and/or au ...
-
Ot Infrastructure
14 hours ago
Genentech Oceanside, United States**The Position**: · - Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market?_ · **We Make Medicines** · Behin ...
-
Product Manager
6 days ago
Acuity Brands Oceanside, United StatesWe use technology to solve problems in spaces, light, and more things to comefor our customers, our communities, and our planet. · Acuity Brands, Inc. (NYSE: AYI) is a market-leading industrial technology company. We use technology to solve problems in spaces, light, and more thi ...
-
Civil Laborer
1 week ago
Motive Companies Oceanside, United States**About Us**: · **Our Client is a full service, self-performing, turnkey, infrastructure solutions provider for the wireless and wireline telecommunications industry. They are a single point of accountability for designing, building, upgrading, and maintaining your networks. No p ...
-
Civil Laborer
6 days ago
Motive Companies Oceanside, United States**About Us**: · **Our Client is a full service, self-performing, turnkey, infrastructure solutions provider for the wireless and wireline telecommunications industry. They are a single point of accountability for designing, building, upgrading, and maintaining your networks. No p ...
-
Manufacturing Engineering Supervisor
6 days ago
General Atomics and Affiliated Companies Poway, United StatesGeneral Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. · Under general supervision with lim ...
-
QA Technician I
14 hours ago
Abbott Laboratories Temecula, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Facilities Technician
5 days ago
Helen Woodward Animal Center Rancho Santa Fe, United States**Facilities Technician** · Full Time (Monday-Friday, occasional nights & weekends) · Pay rate: $20.75/hour · - If you're handy with power tools and have an interest in working in a fulfilling environment, supporting life-saving efforts, come join our team at the world-renowned H ...
-
Automotive Quick Lube Technician
14 hours ago
Capistrano Volkswagen San Juan Capistrano, United States**What We Offer**: · - On-the-job Paid Training · - Tools will be supplied by Capo VW · - Up to date Special Tools · - Laptop computer and Factory VW Scan Tool Computer · - 401(K) Plan with employer contributions · - Paid vacation, holidays, and sick time (when eligible) · - Almo ...
-
Safety Coordinator
1 week ago
PRO ENERGY SERVICES GROUP LLC Escondido, United States**INVITE ONLY** · **Job Summary**: · The primary function of this position is to facilitate compliance with OSHA and customer guidelines to promote and ensure effective safety operations at the division and/or job level. · **Example of Duties** · - Collaborates with operations ma ...
Senior Validation Engineer - Oceanside, United States - TalentBurst, an Inc 5000 company
Description
Title: Validation Engineer III, Req#: ROCGJP
Location: Oceanside, CA (100% onsite)
Duration: 8+ months Contract
Job Description:
A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.
Education and Experience:
Key Responsibilities:
Additional Responsibilities:
Work Environment/Physical Demands/Safety Considerations:
