Manufacturing / Validation Engineer

For engineering services in the manufacturing area.  WHAT MAKES YOU A FIT :   The Technical Part : Bachelor’s Degree in Engineering and two (2) years of experience in the Pharmaceutical or Medical Device industry.

Bilingual (English & Spanish).  Project Management skills.  Shift : Administrative and according to business needs.  Experience in : Validations, protocol writing in a regulated manufacturing environment.

Application and principles of Manufacturing / Process Engineering.

Effectively communicate cross-functionally to assist with resolving Quality / Engineering issues.

Office applications : Word, PowerPoint, Excel.

The Personality Part : Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members.

In other words, being a customer service pro is one your (many) talents.

Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table.

Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL : (The day-to-day on the job) Responsible for coordination of product builds through the NPI processs.

Generates all types of changes to the eLHR system.

Demonstrates basic understanding of regulations (Compliance and EHS) for work area.

Provides recommendations for improvement and executes as needed.

Supports EHS and / or Reg Compliance audits Knowledge of Packaging Engineering Concepts, including packaging validation requirements and materials interaction.

Minimal oversight required for problems or assignments of reasonable difficulty.

Makes decision in a efficient manner.

Considers risk mitigation in planning based on lessons learned or from peers.

Reviews previous similar projects and activities as part of the decision making.  Prepares and provides well thought out contribution to meetings.

Provides technical guidance to peers that facilitates the progression of the project, group or person.

Can present information and collaborates with peers across functions (both internally and externally) .

Exposure to cross functional mgmt.

communications.

Responsible for product / process knowledge and understanding of basic cause and effect of line and process changes.

Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and Manufacturing Aids( from idea definition to implementation).

Support maintenance technicians and supervisors in equipment availability issues.

Responsible for determining quality impact of Out-of-Tolerance documents.

Responsible for execution of line related change management (material, equipment and process changes).

Responsible for simple continuous improvement projects development and execution.

Runs studies and validations on the line as needed.

Writes protocols and reports with oversight.

WHO WE ARE : We are a Service Provider company different from the rest.

We pride ourselves in how we treat the most important piece of our company's puzzle : you!

We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).

Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.  We're FITS!  Are you the Next Piece?

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