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Senior Process Engineer

Company: Nice Pak
Location: Edgerton
Posted on: May 3, 2021

Job Description:

Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The individual will be a key leader within engineering group for managing process engineering activities that include new process development, technology transfer, validation, capital projects for processing equipment and GMP support for processes that support commercial manufacturing. The successful candidate will be a leading contributor during execution of process engineering activities for the department, including troubleshooting problems, analyzing data and optimizing processes. ESSENTIAL FUNCTIONS AND BASIC DUTIES + Leads manufacturing support related work including laboratory and pilot scale studies to support new process development and optimization. + Evaluates new generic platform technologies that can be applied across multiple products. + Leads tech transfer of multiple programs spanning all phases of product lifecycle, including discussions of scale, equipment design and oversight of formulation batches. + Interacts with manufacturing operations staff, troubleshoots problems and supports their operations. + Writing, reviewing and approving of user requirement specifications, functional requirement specifications, validation documentation, and master batch sheets + Organizational support and cross-functional project team leadership and participation. + Responsible to support procuring new processing technologies and processing equipment providing subject matter expertise + Manage formulation matrix to evaluate worst case grouping for cleaning validations + Support qualification and validation of processing equipment and water system. + Manage validation life cycle activities for liquid processing equipment including equipment, process, cleaning validation, and ongoing monitoring + Identify, plan and implement process improvement projects in batching processes. + Technical support for manufacturing with equipment issues, modifications and additions. PERFORMANCE MEASUREMENTS + Successful and timely completion of engineering projects + Successful audit outcomes by internal and external auditors and regulatory agencies + Achieve or exceed cost savings targets QUALIFICATIONS EDUCATION/CERTIFICATION: + Bachelors degree in Engineering; Chemical Engineering preferred REQUIRED KNOWLEDGE: + Proficient in Microsoft Word, Excel, PowerPoint, Mini-Tab (or equivalent) + Working knowledge of formulation tech transfer and scale up + Familiar with design controls, Good Engineering Practices; FDA and ISO regulations (cosmetics, drug, and medical device), and GMP practices EXPERIENCE REQUIRED: + 10+ years of experience in a manufacturing/regulated environment managing complex process engineering projects; New formulation scale up and technology transfer experience SKILLS/ABILITIES: + Excellent verbal and written communication skills + Skilled in technical project management. + Excellent problem solving and interpersonal skills. + Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines. + Use of extensive project leadership experience to drive the planning and management of risks, priorities and contingencies. WORKING CONDITIONS + No hazardous or significantly unpleasant conditions. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Nice Pak, Olathe , Senior Process Engineer, Other , Edgerton, Kansas

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