Senior Technical Transfer Process Analyst I
Kindeva Drug DeliveryAbout the role
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
In this role you will support the technical transfer activities of client projects by developing manufacturing instructions, creating process flow diagrams, analyzing process data for trends and inclusion to reports, and providing training.
Role Responsibilities
• Develop easily understood production instructions based on the client manufacturing process and that conform to company policies and government regulations. This could be in the form of batch records, standard operating procedures, forms and/or training aids.
• Collaborate with cross functional Client and Site teams to reconcile input and alignment on the technical process to be transferred.
• Create production process flow diagrams to support the technical transfer activities.
• Review and analyze production data to develop solutions to problems, to provide trends, and to include in engineering reports.
• Support and track department technical transfer activities ensuring deliverables are completed to meet project timelines.
• Using knowledge, experience and technical skills to evaluate department process and documentation to identify potential improvements and proposed implementation plan.
• Conduct training as required (on-the-job and classroom presentation).
Basic Qualifications
• Education: Bachelor’s Degree in life science, engineering, or equivalent required
• Experience: 5+ years pharmaceutical manufacturing experience
• Knowledge of Quality Systems as it relates to GMP documentation requirements
• Strong technical writing ability with experience writing instructional documents.
• Advanced computer skills that include MS Word, Visio, PowerPoint, Excel, Adobe Acrobat. Ability to work in and create Microsoft Word Templates. Ability to create and revise complex Word documents that include formatting pictures, tables, shapes, and embedded macros
• Excellent verbal and written communication skills
• Interpersonal and communication skills are required to build and maintain working partnerships with all levels of the organization.
Preferred Qualifications
• Experience in aseptic processing preferred
#LI-Onsite
California residents should review our Notice for California Employees and Applicants before applying.
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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