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Validation Engineer III - Des Moines, United States - Kindeva Drug Delivery Company
Description
Posted Monday, January 29, 2024 at 5:00 AMROLE SUMMARY
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies.
We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.Ready to work with purpose? Look no further, we are hiring for a {motivated – talented – passionate, etc.} Validation Engineer III to join our St.
Louis Missouri teamThis position is for an individual contributor to the Quality Operations Validation department.
The successful candidate will assist in the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, perform testing and write validation reports.
Conduct computer systems validation (CSV) on requisite systems. Generate validation protocols using templates. Responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger.ROLE RESPONSIBILITIES
Assists with development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, performs testing and write validation reports.
Generate validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger.Issue data, memos and reports concerning above projects.
Help 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.
Perform special projects as assigned by department manager.Adhere to all company and GMP procedures, along with safety regulations within the plant.
Assist with validation activities performed by outside validation companies; assures that department and company policies are adhered to.
Assist with the Site Change Management Program to keep all finished products, equipment, processes, and facilities in compliance with contemporary industry standards and regulatory filings.
Performs other related duties as assigned.BASIC QUALIFICATIONS
At a minimum, the successful candidate must have a Bachelor's degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and 3+ years experience and/or training, or equivalent combination of education and experience.
PREFERRED QUALIFICATIONS
Computer Systems Validation (CSV) experience is preferred.
Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment and integrated inspection equipment.
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.
To perform this job successfully, an individual should have working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
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.
