Sr Validation Engineer

Location

Rockville, MD | United States

Job description

Validation Engineer – Cangene bioPharma LLC

Location: Rockville, MD 20850

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

ESSENTIAL FUNCTIONS

• Author, review and execute qualification and validation documents with processes, including process equipment and Quality Control analytical instruments.
• Utilize fundamentals of Validation Lifecycle to validate/qualify manufacturing PLC based systems in GXP environment.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Master’s degree in Engineering Management or related field and 5 years of experience as Validation Engineer or related position; OR Bachelor’s degree in Engineering Management or related field and 8 years of experience as Validation Engineer or related position.
• Requires demonstrated experience with validation process in pharmaceutical industry including: fundamentals of Validation Lifecycle (Change Control Management, Risk Assessments, and IQ/OQ/PQ); managing equipment validation, including Commissioning and Qualification, Sterility Assurance, Validation Maintenance/Risk Management; and reviewing validation documentation (user requirements, functional and design specifications, commissioning, and qualification protocols).

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Nearest Major Market: Washington DC

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