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13 days old

Validation Engineer

Kelly Services
Carlsbad, CA 92008
Job Title: Senior Validation Engineer


Location: Carlsbad, CA


Contract Position 6 Months


Description:


When youre a part of our team youll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goal. We are looking for a self-driven, reliable, and resourceful Equipment Validation Engineer to develop and support the successful implementation of manufacturing laboratory equipment.


The role is responsible for Equipment Validation within the Manufacturing Engineering Group of our Carlsbad Manufacturing site. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.


What will you do?


+ Supports execution of equipment validation protocols and associated reports (IQ, OQ, PQ) while adhering to the site Change Management process.

+ Support manufacturing laboratory equipment implementation including but not limited to IOPQs, user requirement specifications, traceability matrices, etc.

+ Work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Equipment Services and other groups.

+ Apply risk-based principles and strategies in the qualification of manufacturing equipment used in the production of commercial manufacturing, packaging, and warehousing of products.

+ Maintain the qualified state of manufacturing equipment throughout the equipment lifecycle in compliance IAW ISO 9001:2015 Quality policies/procedures including support of periodic review, event/time-based requalification, and decommissioning.


+ Author, review and approve Change Control documentations for validation, equipment, facility/utility and/or automation changes. Manage on-time implementation and close-out to meet project, production and supply timelines.


Experience:


+ Minimum of 4-6 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.


+ Hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries preferred


+ Knowledge, Skills, Abilities (Required)

+ Practical application experience in writing, approving of SOP's, IQ, OP, PQ protocols

+ Proficient in Computer applications and software (Microsoft Excel, Outlook, Word)

+ Experience in regulated quality management system standards such as ISO 9001 and ISO 13485.

+ Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts


+ Knowledge, Skills, Abilities (Preferred):

+ Experience in regulated quality management system standards (e.g., 21 CFR Part 820, 21 CFR part 210/211, MDSAP, ICH Q7, Eudralex volume 4 requirements and excipient manufacturing regulations).

+ Global Systems e.g., Agile, Trackwise, LIMS, Master Control, ERP, etc.


Education:

Bachelors degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.


**Why Kelly?**

As a Kelly employee, youll have access to world-class perks, including:

Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

*Group insurance options

Service bonus plan

Holiday pay plan

Weekly electronic pay options

Online training campus that provides more than 3,000 free courses to help improve and develop skills

Exclusive online employee community

Employee assistance program available at no cost

Corporate discounts

Apply Today!


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-06 Expires: 2022-06-06

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Validation Engineer

Kelly Services
Carlsbad, CA 92008

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