Sr Manufacturing Engineer

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life‑enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Independently and collaboratively develops the scope, schedule, and budget associated projects new and upgraded equipment and systems for all areas of the facility, including but not limited to manufacturing, packaging, and facilities; as well as effectively executes and completes project execution safely, within budget, and on schedule. Responsible for small to large projects.

• Works with respective functional group in developing and implementing project scope and cost estimates.
• Works with respective functional group(s), incorporating business data (sales, financial, etc.) where appropriate, to generate a compelling project justification and application for approval of funds.
• Works with all internal stakeholders to develop User Requirement Specifications (URS) for equipment.
• Assists Validation Department with Developing, reviewing, approving, and executing IQ, OQ, PQ, FAT, SAT, equivalency, change in kind documentation as required in the pharmaceutical environment while ensuring compliance to all applicable standards related to the technology including federal, state, and local regulatory codes, as well as customer, operations, and corporate requirements.
• Execute change management process documentation.
• Manage the work of project contractors/vendors.
• Ensure proper end users training for all projects.
• Writes and executes Risk Analysis (i.e. FMEA and Fishbone Diagrams) and Engineering Change Orders.
• Utilizes continuous improvement methodology to improve internal processes.
• Writes/revises SOPs, User Requirement Specs, Functional Requirement Specs, Design Specs, Qualifications, etc.
• Provides engineering support to corrective actions and deviations by identifying root cause and offering solutions.
• When necessary, assist Maintenance Department in resolving high-level technical processing issues related to equipment operation.
• When assigned act as Engineering Department representative on Site wide teams, e.g. safety.
• All other duties as assigned.

• Education: Bachelor’s degree in engineering discipline preferred, or technical experience as determined by the hiring manager.
• Experience: Four (4) plus years engineering experience in pharmaceutical manufacturing environment or other regulated industry.
• Familiarity with ISPE accepted Good Engineering Practices, and scientific terms, principles and concepts required.
• Ability to read & interpret AutoCAD electrical, mechanical schematics, P&.
• Experience with FDA, NFPA and OSHA codes and regulations.
• Working knowledge of MS Word, Excel, PowerPoint, MS Project etc.
• Able to work both independently, within a team, and able to organize and lead a team.
• Strong organizational skills.
• Strong verbal and written communications skills and ability to communicate clearly and efficiently.
• Organizational Relationship/Scope:

  Analytical:
  Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem‑solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information;
  
  integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.

  Drives Execution:
  Coaches, mentors, and motivates project team members and influences them to take positive action and…