Sr Manufacturing Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

• 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.

Minimum Requirements

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.

Other Skills/Competencies:

• Familiarity with ISPE accepted Good Engineering Practices, and scientific terms, principles and concepts required.
• Ability to read & interpret AutoCAD electrical, mechanical schematics, P&ID drawings
• 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 accountability for their assigned work. Demonstrates effective skill in planning, supervising, monitoring, and accomplishing projects. Knows how to organize people, activities, and processes to get things done efficiently and effectively. Exhibits passion for driving process and projects, and for achieving success through continuous innovation and execution to plan.

Project Management: Knows how to organize people and activities; can see opportunities for synergy and integration where others can't; coordinates the diverse components of projects by quality project planning, execution and change control to achieve the required balance of time, cost and quality; manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives.

Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.

Business case development: Uses financial analysis to evaluate and create strategic choices and options; knowledgeable about how the business and organization work; knowledgeable in current and possible future policies, practices, trends, and information affecting the business and organization; understands the competition; is aware of how tactics work in the marketplace; devises an approach that best positions an idea, plan or activity; leverages supportive factors, breaks through barriers, and addresses the unique needs and preferences of key decision makers.

Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.

Shift: Days Mon-Fri

Salary range: $80,000 - $100,000

+ bonus

+ great benefits from day one

+ relocation package