Validation Engineer I

job summary:
With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, quality policies, standards and core values. Maintains company's right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects.

location: Vacaville, California
job type: Contract
salary: $26.58 - 44.30 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
Duties:

Technical:

• Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
• Coordinate with laboratory personnel to define qualification requirements.
• Author, review and execute equipment qualification protocols.
• Coordinate equipment qualification activities with vendors and other support groups.
• Identify business, quality, and compliance gaps.
• Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

 
qualifications:

Education:

- BS/BA degree (preferably in relevant scientific discipline)

- Experience (may vary depending on site size/scope)

- Experience in the pharmaceutical, biopharmaceutical industry or an equivalent combination of education and experience.

- Knowledge of cGMP or equivalent regulations.

- Minimum of two years' experience in Validation or equipment qualification is desired.

- Ability to make sound decisions about scheduling and managing of priorities.

- Flexibility in problem solving, providing direction and work hours to meet business objectives.

Knowledge/Skills/Competencies:

- Possesses strong verbal and written communication skills and the ability to influence at all levels

- Capable of building trustful and effective relationships

- Able to think strategically and translate strategies into actionable plans

- Takes responsibility, drives results, and achieves expected outcomes

Work Environment/Physical Demands/Safety Considerations:

- Standard office environment

skills: Good Manufacturing Practices (GMP), Process Validation, Equipment Validation, Quality Assurance (QA), Quality Control (QC)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.


Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.