QA Validation Analyst/Engineer

Job Title: QA Validation Analyst/Engineer
Location: Barceloneta, PR
Contract Length: 08+ months
Pay Range: $45/hr - $47/hr

What are the top 3-5 skills, experience or education required for this position:

1. Proficiency using Kaye Validator and TempTales to perform temperature mapping studies

2. Qualification / Validation of temperature/RH controlled chambers (temperature/RH mapping for freezers, incubators, cold rooms, refrigerators, ect.)

3. Experience completing Equipment/ Utilities/Facilities Validation Periodic Reviews, including evaluation or Risk Assessments

4. Sterilization cycles qualifications for autoclaves and Steam In Place (SIP)

5. Cleaning Validation for Clean In Place (CIP) and automated washer equipment

BA Sciences

3-5 Years of experience

Job Description:
The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level.The Validation Engineer responsibilities may include: the review of commissioning and validation? documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review? and approval of critical planned maintenance routines, set-up of laboratory samples for qualification, participation in the establishment of plant quality systems, supporting regulatory and third party audits.

Responsibilities:

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.

• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

• Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.

• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.

• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.

• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.

Qualifications:

• Bachelor's degree, preferably in Biology, Chemistry or Engineering

• Prefer 2+ years of overall experience in Manufacturing, Quality or Engineering

• Good verbal and written communication skills.

• Good problem solving and analytical skills

• Good interpersonal relations / communications skills

• Good negotiation skills

• Prefer knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.