Validation Quality Engineer I

Posted Friday, February 2, 2024 at 5 : 00 AM

Are you the right applicant for this opportunity Find out by reading through the role overview below.

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 Validation Quality Engineer I to join our St. Louis Missouri team!

ROLE SUMMARY

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy, or related science.

Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.

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).

ROLE RESPONSIBILITIES

Assists with development of Aseptic product manufacturing equipment qualification / validation, Cleaning Validation & Process validation protocols, performs testing and writes validation reports.

Generate validation protocols using templates. Primary responsible for 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.
• 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

BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and 3 plus years related experience and / or training;

or equivalent combination of education and experience.

Preferred Qualifications

• 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).

Physical / Mental Requirements

• While performing the duties of this job, the employee is occasionally exposed to general laboratory and / or manufacturing areas;
• work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate;

required to stand; walk; sit; talk or hear; must occasionally lift and / or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus.

Position requires regular onsite attendance this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

Non-Standard Work Schedule, Travel or Environment Requirements

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements.

Must have the ability to work effectively under and manage to strict production, time, and performance deadlines. Must be willing and able to work beyond the hours typically defined as a regular workday, which may or may not include weekends and holidays.

If necessary travel to other locations.

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.

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