Senior Validation Engineer

Our Work Matters

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 protocols and perform testing and write validation reports.

Role Responsibilities

Generate validation protocols using templates.
Protocol execution of various types of basic processing equipment under the direction of Validation Manager.
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.
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.

Qualifications

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science.
7+ years related experience and/or training, or equivalent combination of education and experience.
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.
SITE

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Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

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.

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