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Process Engineer / Pharma Injectable Manufacturing (Remote-work)

Company: Pioneer Data Systems Inc
Location: Saint Louis
Posted on: May 6, 2021

Job Description:

Our client, a world-leading Pharmaceutical Company in Kalamazoo, MI is currently looking for a Process Engineer / Pharma Injectable Manufacturing (Remote-work) to join their expanding team. Position Details: Job Title: Process Engineer / Pharma Injectable Manufacturing (Remote-work) Duration: 9 months contract, extendable up to 18 months Location: Kalamazoo, MI Note: The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract. You may participate in the company group medical insurance plan Job Description: The individual selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements The individual will be responsible for coordinating the development of a disposables strategy for PGS. The strategy will target the establishment and maintenance of network-wide design, quality, and operational standards, along with lifecycle management, and sourcing strategies for disposable items. In addition the role will be key in representing Pharmaceutical's interests with external organizations. This role will work with network partners and SME's to understand the disposable requirements, develop appropriate specifications, drive alignment and robustness of the portfolio with suppliers, and troubleshoot issues. This position requires effective and direct communication skills, bold leadership and facilitation, and the ability to influence and integrate various colleagues from all levels of the organization.

Job Requirements:Role Responsibilities: As a Single Use System Subject Matter Expert your responsibilities could include: Technical Act as Disposables SME for sites to support implementation of best practices and solutions Provide advanced technical subject matter expertise and issue resolution for major/complex investigations involving single use assemblies and components across all business units Develop processes / procedures to facilitate single use system design discussions with Network partners. Applies technical knowledge and project management skills to achieve goals of the department Ensure compliance with relevant regulations and guidance Managerial Comfortable with multifunctional and multi-cultural environments. Effective influencer, motivator and communicator. Maintaining project updates in IMEX VMB and other methods, as requested Good influencing skills and ability to work in a matrix organization to deliver results Experience facilitating cross-functional decision-making across center and site functions. Interpersonal Effectiveness Able to influence team members across different organizations Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all PGS stakeholders Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, QA, PharmSci, Procurement, and GCMC Approach / Mindset Recognizes cross-functional impact in all decision-making; proactively reaches out to external stakeholder groups to gain alignment on cross-functional issues Able to identify root causes and drive to problem resolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity in problem solving Knows when to report or escalate risks and issues to leadership Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance Embraces Pharmaceutical Purpose: Breakthroughs that change patients' lives through the incorporation of the Bold Moves and Values and Behaviour's Requirement: Masters or Bachelors with minimum 3-5 years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience Operations or Tech services experience Experience in polymeric materials is a plus Green Belt experience is an advantage Minimum of three years' experience in project management/execution role is advantageous Knowledge of cGMP requirements and compliance Excellent communication and technical writing skills Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities Comments: Remote is OK Prefer near a Pharmaceutical site Sanford NC , MI or MA within 2 hours Please send candidate phone number and email when confirm invite Must have single use technologies on drug substance or drug product side with single use technology and qualifications Helping managing and driving project

Keywords: Pioneer Data Systems Inc, St. Louis , Process Engineer / Pharma Injectable Manufacturing (Remote-work), Other , Saint Louis, Missouri

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