JT727 - VALIDATION SPECIALIST

Villalba, Puerto Rico

Temporary

Medical Devices

Mid Level

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

Evaluate the impact of validated computerized systems on existing work instructions and processes.
Prepare and execute computer system validation protocols and generate comprehensive reports.
Develop and maintain Installation Qualification (IQ) documentation.
Collaborate with process owners to implement changes to work instructions and ensure compliance.
Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
Ensure adherence to company procedures, quality system regulations, and industry standards.
Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques.
Organize and track project progress, maintaining detailed documentation and status updates.
Contribute to cross-functional projects and support milestone completion.
Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.

Qualifications:

Bachelor’s degree in Engineering
Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
Practical knowledge and demonstrated competence in validation and quality systems
Investigation and root cause analysis skills
Technical writing knowledge
Organization and Communication skills
Process Validation and Computer software validation knowledge
Experience in SDLC
Experience in medical devices or other highly regulated industry (e.g., medical devices, pharmaceuticals, biotech)
Excellent verbal and written communication skills in both English and Spanish
Availability to work 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Apply for this position

Required*

First Name*

Last Name*

Email Address*

Phone*

Address

Resume*

We've received your resume. Click here to update it.

Attach resume or Paste resume

Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

Do you possess a Bachelor's degree in Engineering?*

Do you have experience in process or system validation?*

Do you have experience working in a medical device industry?*

Are you available to work 1st shift?*

The following questions are entirely optional.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran

A “disabled veteran” is one of the following:
- a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
- a person who was discharged or released from active duty because of a service-connected disability.
A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran status

I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE
I AM NOT A PROTECTED VETERAN
I DON’T WISH TO ANSWER

Voluntary Self-Identification of Disability

Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Please check one of the boxes below:

YES, I HAVE A DISABILITY, OR HAVE HAD ONE IN THE PAST NO, I DO NOT HAVE A DISABILITY AND HAVE NOT HAD ONE IN THE PAST I DO NOT WANT TO ANSWER

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Name	Date

Human Check*

Submit Application