Posted Monday, February 5, 2024 at 5:00 AM | Expired Wednesday, March 13, 2024 at 3:59 AM
Kindeva is a global pharmaceutical contract developer and manufacturer (CDMO) business headquartered in St. Paul, MN. Kindeva was established following 3M’s sale of substantially all its drug delivery business to affiliates of Altaris Capital Partners.
Kindeva is navigating a period of dynamic change and growth as a result of the sale and business opportunities in its pipeline. Kindeva partners with global pharmaceutical companies to commercialize products, primarily through inhalation and transdermal delivery technologies.
We are looking for a talented Pharmaceutical Validation Professional to join our team. Much of what we do is to GxP standards. In this role you will provide vital scientific support to our R&D colleagues in Kindeva, which employs across the UK and US. The role would include technical support in our Laboratory Services Department, and other services to the R&D community.
Summary of Position:
The role entails the support in the R&D Laboratory Services organization for the management of the Laboratory Equipment. This includes ensuring that equipment is compliant, operational, and maintained throughout its lifecycle. This can be achieved by ensuring that equipment is qualified and calibrated, providing technical support to the end users, software administration, and requalification. In addition, other support services include ensuring that the Laboratory Services department remains compliant and operational at all times by ensuring critical activities are completed promptly.
Job Responsibilities:
* Laboratory Equipment Management
o Ensuring the equipment is operational, calibrated, and compliant to GxP Standards.
o Ensuring that the equipment is qualified (i.e., IQ, OQ, and PQ) as per the regulatory requirements and in compliance with the procedures.
o Ensure all necessary documentation e.g., creating and executing qualification protocols and reports are completed according to the timelines.
o Undertaking routine software administrative support of the equipment.
* Supporting and working with the end users to ensure that the laboratory remains compliant, and the equipment is available as per the timelines.
Key Working Relationships:
This role must maintain strong working relationships cross-functionally with business leaders, employees, and external partners across the global enterprise.
Skills & Experience:
* Min 2 years relevant work experience in a Pharmaceutical GxP environment.
* Familiarity in the use of applications such as Laboratory Information Management System (LIMS), Chromatography Data Systems (e.g., Empower), and Electronic Laboratory Notebook (ELN).
* Familiarity with the analytical equipment such as High-Performance Liquid Chromatography, Gas Chromatography.
* Bachelor’s degree from an accredited university in analytical sciences or related field.
* Excellent interpersonal and organizational skills to interface with internal customers, management, and outside vendors.
Location: Primarily, this role is based in Loughborough, UK to support our R&D colleagues in person.
What we will give to you:
Attractive compensation package.
Company pension scheme (up to 10% employer contribution).
25 days holiday per year (plus bank holidays) plus service days after 5 years.
Company sick pay.
Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
Life assurance of four times life cover salary.
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