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Job Summary:
Simtra BioPharma Solutions is a Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies. The Process Engineer will be responsible for developing, executing, and managing engineering projects related to processing and packaging, collaborating with cross-functional teams to ensure project success.
Responsibilities:
• Depending on level, will participate in or leads team in defining project strategies, developing goals and ensures project scope is defined to meet project requirements
• Continuously interacts with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Assists other project manager to ensures identification and communication of projects risks, development of risk plan and leads team in the proactive management of risk response strategies
• Anticipates potential conflict situations and manages to a successful outcome
• Assists project managers to track team deliverables for project completion
• Assists project manager to create and maintain project schedule
• Assists project manager to control project scope creep
• In collaboration with the team, establish, track and communicate project risks
• Participates in all collaborations with external engineering firm in feasibility assessments, concept design, basic design and detail design
• Participates in technical review of all external engineering design reviews
• Assists project manager in reviewing contractor/engineering firm submittals
• Develop project URS, RFQs, CCMs, Work Orders, preventative maintenance plans, P&ID redlines, spare parts management among other activities directly related to project documentation
• Collaborates with multifunction teams to develop project Capital Expenditure Requests (CERs) and Front-End Loading (FEL) documents among other documents required to obtain project approvals.
• Assists with project IQOQ & PQ activities
• Participates in training site stakeholders as project is turned over to the site
• Presents project technical scope to site stakeholders and project sponsors/endorsers
• Participates/leads project technical reviews for assigned projects
Qualifications:
Required:
• BS degree in any Engineering field
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8-15 years of experience (Level IV/Principal)
• 15+ years of experience (Level 5 / Sr. Principal)
• Strong oral and written communication skills
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, and Teams)
• Ability to learn how to use enterprise software
Preferred:
• Preferred experience in working in an aseptic manufacturing plant (processing and/or packaging)
Company:
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies. Founded in 1930, the company is headquartered in Parsippany, New Jersey, USA, with a team of 1001-5000 employees. The company is currently Late Stage.
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