Aseptic Process Engineer II

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 Aseptic Process Engineer is a key technical role responsible for ensuring consistent high performance of aseptic manufacturing processing areas. The role requires specialized aseptic manufacturing and compliance experience. The incumbent will provide focused technical ownership over manufacturing processes while driving quality, the implementation of best practices, and continuous improvement. As the technical lead on aseptic compliance, the Aseptic Manufacturing Engineer partners with production, quality, and compliance colleagues to identify and implement innovative solutions. Additional duties include project management, six sigma methods, and training coordination.

ROLE RESPONSIBILITIES
Observe, analyze, and identify aseptic process improvement opportunities on the manufacturing floor.
Effectively manage and coordinate aseptic manufacturing projects and other functions at the site in support of technical projects.
Partner with Sterile Product Manufacturing (SPM) principals, Quality Assurance (QA), and other internal experts to develop quality investigations, assign root cause, and identify/implement CAPA solutions.
Work with Quality Operations and Regulatory Affairs to ensure regulatory filings are completed on time and to the appropriate standard.
Champion Process Change Proposals/Requests as relates to technical support operations.
Act as internal technical and compliance training resource for both SPM Management and SPM production floor team.
Ensure work activities are conducted in strict accordance with safety guidelines and processing standards, such as FDA's current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).
Aseptic Qualifications are completed and maintained.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

BASIC QUALIFICATIONS
Bachelor's degree in science (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)
2+ years of experience in pharmaceutical manufacturing and background in manufacturing or quality.
Previous aseptic manufacturing experience preferred.
Six-Sigma training and project management experience is preferred.

Technical Skills:
Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
The candidate must demonstrate proficiency in organizational and management skills and must be able to balance multiple priorities to meet established timelines.
Ability to clearly present technical information and effectively communicate within all levels of the organization.
Demonstrated ability to contribute to and lead project teams.
Clear thinker: simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information and communicating priorities clearly and concisely.
Must be able to apply solid reasoning skills to an investigation and to project planning.
Must be self-motivated and flexible to learn and respond to changing responsibilities and priorities.
Demonstrated commitment to values-based leadership and achieving objectives in a manner that is consistent with Kindeva Values.
Strong commitment to product quality and continuous improvement, with working knowledge of RFT principles.

#LI-onsite #LI-BM1


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.

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