Process Engineer III

Job title: Process Engineer III

Company: Croda

Job description: Process Engineer IIIVacancy Number: 4178Location: Alabaster, ALLocation Address: 700 Industrial Park Drive, Alabaster, AL 35007Be part of our journeyAs a global leader in specialty chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable and high-performance solutions. We are passionate and excited about developing and utilizing new technologies to shape and inspire changes within an ever-growing marketplace.Summary:The Process Engineer III is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment. These activities include designing studies and processes, writing and executing protocols for testing equipment, product and processes, and summarizing results into technical reports. Assists in troubleshooting, equipment and facility design, and managing commissioning, validation and revalidation projects.Responsibilities:
Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing manufacturing processes
Assist in the design and procurement of new equipment and lead commissioning, start-up, installation, or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports.
Assess equipment changes (repairs, replacement, automation, improvements, etc.) for impact to validated processes and, if necessary, perform process qualification or re-validation.
Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements
Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments.
Write procedures, protocols and technical reports for manufacturing, utility, performance qualifications, lab equipment, cleaning and process validation
Compile validation packages and assure all required documentation is accurate and complete
Champion process improvement projects and ensure equipment and systems remain in a qualified stateInvestigations:
Lead or assist in general investigations (from deviations, OOS Investigation, Batch Failures, customer complaints, etc.).
Lead or assist in equipment/process related risk assessment exercises for:
potential changes to equipment/processes,
impact assessment for deviations to processes/equipment
Various techniques, such as Root Cause Analysis (RCA), and Failure Mode and Effects Analysis (FMEA) may be employed during investigations.
Ensure thoroughness of investigation, including documentation and closure.
Lead or assist in equipment/process related risk assessment exercises for potential changes to equipment/processes.
Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
Point person for process improvement activities; including performing or authoring equipment specifications, develop, or assist with development by subject matter experts, user and functional requirements specifications for new equipment , and necessary FAT and SAT protocols (as required).
Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, and support of out-of-tolerance investigations related to instrument calibrations
Other duties as assignedOther Skills and Abilities:
Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems and controls, or within a specific scientific / technical discipline.
Excellent working knowledge of cGMPs and regulatory requirements is preferred
Excellent technical writing and organizational skills; extremely detail oriented
Good mechanical aptitude
Good interpersonal skills and the ability to work well in a team environment
Self-starting with outstanding work ethic; must be able to perform in a fast-paced multi-product environment
Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.
Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements
Strong listening, writing, reading, and verbal communication skillsEducation and Experience:
BS degree in Chemical Engineering or related life science
Minimum of 10 plus years of previous relevant work experience in a related field required.
Experience providing technical support in a cGMP manufacturing environment including hands-on process development, optimization and troubleshooting of equipment and processes is preferred
Experience with any of the following: process equipment, filling or packaging equipment, cleaning validation planning and execution, piping and instrumentation diagrams (P&ID), chemical process engineering and pharmaceutical process development is preferred. Application Information:
Croda recognizes employees as our strength and the diversity they bring to our workforce are directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including age, race, color, religion, national origin, gender, sexual orientation, gender identity, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as any mental health or physical disability needs.
Equal Opportunity Employer/Disability/Veterans. This Organization Participates in E-Verify.

Expected salary:

Location: Alabaster, AL

Job date: Sat, 17 Aug 2024 05:21:29 GMT

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