Services

Validations Engineer

The post holder will have direct responsibility for process validations and equipment qualifications planning and execution. These include, but are not limited to, Installation / Operational Qualifications (IQ/OQ), Process Characterization and Performance Qualification (PQ) intended to provide documented evidence that, the process, equipment and/or facilities have been installed and will consistently operate and perform according to predetermined (design) requirements specifications.

The post holder will have direct responsibility for process validations and equipment qualifications planning and execution. These include, but are not limited to, Installation / Operational Qualifications (IQ/OQ), Process Characterization and Performance Qualification (PQ) intended to provide documented evidence that, the process, equipment and/or facilities have been installed and will consistently operate and perform according to predetermined (design) requirements specifications.

Essential Duties and Responsibilities

a. Development and execution of IQ, OQ, PQ prototols and reports, Test Method Validations (TMVs), and creation / revision of Manufacturing Instructions (MIs), Standard Operating Procedures (SOPs), data collection Forms by initiating CRs and COs through the Change Control process.

b. Perform corresponding Risk Assessments required as part of Change Control process.

c. Ensure timely and efficient completion of assigned qualifications and validations activities.

d. Ensure tasks and activities performed comply with applicable cGDP/cGMP regulations and Standard Operating Procedures (SOPs).

e. Instruct / train mfg. personnel and shift supervisors on qualification / validations protocols, and revised documents (WIs / SOPs) to ensure adequate execution, consistent output and fully compliant final product.

Knowledge and Background Requirements

a. Understanding of Lean Six Sigma tools to a practical level for effective application.

b. Computer literate (MS Office, Minitab, MS Project).

c. Good written and oral communication in English and Spanish languages

A. Education & Experience:

1. Bachelor's degree in Engineering or other Technical Area.

2. 2+ years in qualifications and validation development and execution.

3. Lean/Six Sigma concepts training & application (certification preferred)

4. 1+ years in a GMP regulated manufacturing (preferred)

B. Competencies, Traits and Skills:

1. Customer service oriented: Must have good interpersonal and communication skills to provide adequate service to internal and external customers. Must maintain a high level of confidentiality, standard of ethics and integrity.

2. Able to effectively work, communicate (written and oral) and collaborate with peers and other business areas.

3. Computer knowledge of various applications- to include Microsoft Office package (Word, Excel, Outlook), MS Project, Adobe Acrobat, Minitab Statistical software.

4. Change Management: must be able to develop workable implementation plans and communicate changes effectively.

5. Effective Prioritization, Planning and Time Management: Must be able to organize and plan workload on several projects concurrently to meet deadlines.

Interested? Driving our future growth requires talented people. Sartorius is a dynamic organisation suited to people who want to showcase skills, be recognised for expertise and thrive in a vibrant and innovative environment.


To find out more about Sartorius as an employer visit us on Sartorius Careers

Become part of our global team.

  • Reference Number R1521
  • Job Begin February 27, 2020
  • Employment Mode Full time
  • Position Regular
  • Functional Area Services
  • Location Yauco (Puerto Rico)