- Katalyst HealthCares and Life Sciences (Lake Forest, IL)
- …Director level stakeholders. Requirements: BA or BS degree in Business, Computer Science , Data Science , Mathematics, or related technical field. 0-1 year ... of analytical and/or related operations experience strongly preferred, ideally within the pharmaceutical and/or healthcare industry. Strong working knowledge and experience with SQL, Dataiku, and Power BI. Snowflake experience preferred. Strong proficiency in… more
- Katalyst HealthCares and Life Sciences (Conshohocken, PA)
- …Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions. The ... ability to lead and/or support multiple projects simultaneously. Defines technical or scientific direction of programs composed of multiple complex projects. Engineers new and modifies existing processes to ensure right first-time process startup. Track record… more
- Katalyst HealthCares and Life Sciences (Round Lake, IL)
- …This position is a contract Packaging Engineering position within Client's Pharmaceutical segment R&D group. With some supervision, performs sustaining engineering ... activities on current product packaging and packaging processes with priorities based on quality and compliance, continuity of supply, and cost savings initiatives. When applicable, will support new product development teams by acting as an extended team… more
- Katalyst HealthCares and Life Sciences (Irving, TX)
- …Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications - Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace ... Matrix, Summary Reports etc. Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications.… more
- Katalyst HealthCares and Life Sciences (Austin, TX)
- …on Natera training requirements. Requirements: BS/BA in a biological science /biomedical engineering, similar field of study, or comparable industry experience. ... 1 year of industry-related experience. Experience supporting lab equipment or similar required. Ability to analyze and problem solve issues. Excellent attention to detail and accuracy. Ability to promote a positive team environment. Adaptability in a… more
- Katalyst HealthCares and Life Sciences (Swiftwater, PA)
- …Must have Experience in authoring, reviewing, executing and approving validation documents. Interface with Quality organization and the ability to defend rationale in ... validation documents. Ability to develop cleaning cycle and lead the investigation or trouble shooting. Ability to review and analyze data. Cleaning Validation experience. Acceptance criteria determination. Sampling plans and sample size determination. Rinse… more
- Katalyst HealthCares and Life Sciences (Columbia, MD)
- …Requirements: Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences /relevant discipline. 3+ years pharmaceutical. 1-3 years cross functional project ... management. 4 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3). May require an advanced degree and 2 to 5 years of direct experience in the field. Recent experience with Class III implantable… more
- Katalyst HealthCares and Life Sciences (Lititz, PA)
- …Designs comprehensive engineering activities to develop and implement effective high-quality processes and design guidelines for dissemination throughout the ... division. Provides complex design reviews and feedback for improvements in manufacturability. Will facilitate technology transfer from process development to commercial-sale processes for new product introductions, lead and coordinate all activities to modify… more
- Katalyst HealthCares and Life Sciences (Portsmouth, NH)
- …The Category Buyer is responsible for Capex Process Equipment procurement activities for Lonza USA sites of approximately $10m to $500m. The Category Buyer is ... responsible for all assigned procurement activities related to process equipment for projects across North America. This role supports Lonza's strategic growth and investments, delivering new manufacturing capacity. Responsibilities: Supports category strategy… more
- Katalyst HealthCares and Life Sciences (Athens, GA)
- …Communicate business related issues or opportunities during QA Value Stream Meeting. Support internal/external audit execution and deliverables as required. Review ... effectiveness of investigation against an established process. Analyze proposed changes to determine if the change will result in non-compliance. Assess the need for techniques for risk mitigation given potential defects, defect type and frequency.… more
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- …As a Quality Engineer II, you will be a key contributor to the implementation, maintenance, and continuous improvement of the Quality Management System (QMS). You ... will collaborate cross-functionally to ensure compliance with regulatory requirements, drive root cause investigations, and support quality initiatives that enhance product and process performance. Your role will be instrumental in ensuring that quality… more
- Katalyst HealthCares and Life Sciences (La Verne, CA)
- …6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for ... Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification,… more
