Search TSR Jobs

About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Sr. Specialist, Project Leader

Job Description

  • Location: Devens, MA
  • Type: Contract
  • Job #67539

Our client, a leading pharmaceutical company is hiring a Sr. Specialist, Project Leader on a contract basis.

Work Location

Devens, MA

Summary:

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education and Experience • Bachelors degree in a related field from an accredited college or university required.

• Minimum of 4 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.

• Strong project management skills are needed. Minimum of 1 year of experience with project coordination and cross-functional team leadership preferred.

• Minimum of 1 year of experience supporting electronic batch records, preferably Syncade MES.

• Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.

 

DUTIES AND RESPONSIBILITIES:

• Apply manufacturing process expertise and electronic batch record technical knowledge to own electronic batch record changes and the associated change controls.

• Own Electronic Batch Record (MES/Syncade) Functional specifications. Ensure consistent execution of recipe modifications and changes. Ensure adherence with governing documents related to change management.

• Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MS&T to ensure change initiatives are driven to closure, and migrated to the production area in a timely manner.

• Owns the lifecycle of an electronic batch record change

• Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development.

• Understanding of MES library objects. Use that understanding to direct changes to MES recipes and/or directly update the MES recipes utilized in Manufacturing.

• Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.

• Execute testing of the recipes in the development environment to ensure functionality.

• Manage User Acceptance Testing process for recipe qualification.

• Provide technical support by troubleshooting and resolving MES issues to support manufacturing operations.

• Develop and deliver reports from reporting software.

• Able to use creative problem solving. Provides technical expertise to management and less experienced professionals.

• Perform other tasks as assigned.

 

 

Include a message to the recruiters.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!