What are the responsibilities and job description for the Validation Engineer position at United Pharma?
Role: Validation Engineer
Location: NJ (Onsite)
Duration: 12 Months Contract on W2
Job Description:
We are seeking an experienced Validation Engineer with a strong background in biopharmaceutical or life sciences manufacturing environments. The ideal candidate will have hands-on experience with upstream process equipment and a solid understanding of validation practices.
Key Responsibilities:
* Perform commissioning, qualification, and validation (CQV) activities for manufacturing equipment.
* Develop and execute validation protocols including IQ, OQ, and PQ.
* Work with upstream equipment such as:
* Bioreactors
* Pump skids
* Buffer vessels
* Other related process equipment (“upstream equipment”)
* Ensure compliance with GMP (Good Manufacturing Practices) and regulatory requirements.
* Collaborate with cross-functional teams including Engineering, Quality, and Manufacturing.
* Review and approve validation documentation and reports.
* Support deviation investigations, CAPA, and change control processes.
Required Qualifications:
* Bachelor’s degree in Engineering, Life Sciences, or related field.
* 1-3 years (or more) of validation experience in pharma/biotech industry.
* Hands-on experience with:
* Bioreactors
* Process skids
* Buffer preparation systems
* Strong knowledge of CQV lifecycle and documentation practices.
* Familiarity with regulatory standards such as FDA, GMP, and ISO guidelines.
Preferred Skills:
* Experience in upstream processing environments.
* Knowledge of automation systems (DeltaV, SCADA, etc.) is a plus.
* Strong problem-solving and documentation skills.