Senior Validation Engineer

Kindeva Drug Delivery; Bridgeton (MO); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Validation Engineer to join their team. In this pivotal role, you will contribute to the development and validation of aseptic product manufacturing equipment, ensuring compliance with industry standards and regulatory requirements. Your expertise will help shape the future of healthcare by guaranteeing that products meet the highest quality standards. This role offers an exciting opportunity to work on critical validation processes and collaborate with a dedicated team in a state-of-the-art facility. If you are passionate about making a difference in the pharmaceutical industry, this position is for you.

Benefits

Relocation Assistance

Qualifications

• 7+ years of validation experience in an aseptic environment.
• Bachelor’s degree in a related science field required.

Responsibilities

• Assist in developing validation protocols for aseptic manufacturing equipment.
• Ensure compliance with industry standards and regulatory filings.

Skills

Validation in Aseptic Environment

Knowledge of cGMP

Analytical Skills

Technical Writing

Microsoft Office Suite

Education

Bachelor’s degree in Chemistry

Bachelor’s degree in Biochemistry

Bachelor’s degree in Microbiology

Bachelor’s degree in Engineering

Bachelor’s degree in Pharmacy

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Access

Microsoft Project

Job description

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Senior Validation Engineer will assist in the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation, Process validation, computer systems validation, perform testing and write validation reports. This individual will generate validation protocols using templates and be responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manager.

This role is required to be on-site at the Bridgeton facility and relocation assistance is available for qualified candidates who are not local to the St. Louis area.

Essential Job Functions:

1. Assists with development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, computer systems validation, performs testing and writes validation reports. Generates validation protocols using templates. Primary responsibility for protocol execution of various types of basic processing equipment under the direction of Validation Manager.
2. Helps to determine process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch records.
3. Assists with validation activities performed by outside validation companies; assures that department and company policies are adhered to.
4. Assists with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.

Basic Qualifications:

1. Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science.
2. 7+ years validation related experience in an aseptic environment.
3. Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
4. Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment and integrated inspection equipment.
5. Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; able to readily identify/report deviations to management in a timely manner.
6. To perform this job successfully, an individual should have a working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!