Similar posts
Senior Validation Engineer - Biopharma
- Permanent
- Manufacturing
- United Kingdom
As a Validation Specialist, your primary focus will be supporting the engineering team by defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment. This includes conducting IQ, OQ, and PQ studies to ensure optimal performance and output.
Additionally, we are expanding our capabilities with the addition of a new Drug Product facility.
Key Responsibilities
- Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry standards.
- Act as the Subject Matter Expert for specific validation activities as designated by the Qualification and Calibration Manager.
- Investigate and resolve non-conformances found during requalification, revalidation, and periodic review activities, with support from senior validation team members.
- Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc., ensuring risks are properly identified and documented.
- Identify and implement Continuous Improvement initiatives to promote lean processes.
Key Requirements
- Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
- Strong understanding of qualification and validation lifecycles.
- Knowledge of current regulatory requirements and industry standards related to validation activities.
- Proven experience in executing qualification and validation tasks such as IQ, OQ, PQ.
- Technical, compliance, and practical knowledge of specific validation activities, as guided by the Validation Manager.
- Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
- Proficient in creating and reviewing technical documentation.
If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
天涯社区官网 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 天涯社区官网 is acting as an Employment Agency in relation to this vacancy.
Related jobs
Highly Competitive
Philadelphia, USA
天涯社区官网 is working alongside a biotechnology to recruit for a Support Services Associate I. This is a temporary contract position based in Philadelphia, Pennsylvania.
Highly Competitive
Budapest, Hungary
天涯社区官网 is currently recruiting for an experienced individual in Quality Control for a managerial position. This role is on a permanent contract and is based in Budapest, Hungary.
Highly Competitive
Framingham, USA
Validation Engineer II - Contract - Framingham, MA
Highly Competitive
Cambridge, USA
Manufacturing Associate - Contract - Cambridge, MA 天涯社区官网 is seeking a dedicated Manufacturing Associate for a role based in Cambridge, MA.
US$25 - US$28 per hour
Fremont, USA
天涯社区官网 are working alongside a pharmaceutical company to recruit for a Facilities Specialist. This is a temporary contract position based in Freemont, California.
Highly Competitive
Hertfordshire, England
天涯社区官网 are collaborating with a pharmaceutical company to recruit for a Senior USP Scientist. This is a permanent position based in Hertfordshire, United Kingdom.
US$70000 - US$80000 per annum
Gaithersburg, USA
天涯社区官网 is working alongside a pharmaceutical company to recruit for a System Engineer. This is a temporary contract position based in Gaithersburg, Maryland.
Highly Competitive
Social Circle, USA
Manufacturing Associate - Contract - Social Circle, GA
Highly Competitive
Gaithersburg, USA
天涯社区官网 are working alongside a pharmaceutical company to recruit for a Research Associate, Downstream Process Development on a temporary contract based in Gaithersburg, Maryland.
Highly Competitive
Gaithersburg, USA
天涯社区官网 are working with a pharmaceutical company to recruit for an Associate Scientist for Downstream Process Development on a temporary contract based in Gaithersburg, Maryland.