Quality / Validation Engineer
3 days ago
OVERVIEW:
Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality / Validation Engineer.
** JOB ID: JP00049892
** JOB TITLE: Quality / Validation Engineer
** LOCATION: Onsite Role | 10975 Torreyana Road San Diego CA 92121
** DURATION: 9 months +
Pay Rate: $35.00/hr. - $37.00/hr. (depends on experience)
JOB RESPONSIBILITIES:
- As directed by the Quality Engineering Leader, the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies.
- Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
- Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.
- Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.
- Review and update FMEA or Risk documents as needed for validation activity for the sitePerform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area.
- Duties include but not limited to execution of QA inspection to support dual operations, review and approval of documents such as batch records to support finished product release.
JOB REQUIREMENTS:
- Education: BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field.Minimum of 3 years of experience in Quality/Validation Engineering.
- Hands-on experience in equipment execution and validation.
- Experience with Class 1 & 2 Medical Devices (focus on validation, not manufacturing).
- Strong Excel proficiency (required).
- Minitab experience preferred but not mandatory (training provided if necessary).
- Background in Chemistry or Biology (reagents knowledge is relevant).
- Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out of Tolerance activity support to the site and equipment owners.
- Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities
- Emphasis on experience in validation over manufacturing.
I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.
Recruiter Name: Lalit Malgotra
Title: Lead Recruiter
Email ID: lmalgotra@ameritconsulting.com
Company Overview:
Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.
Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.
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