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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.

Validation Engineer

Job Description

  • Location: Devens, MA
  • Type: Contract
  • Job #75690

Our client, a leading pharmaceutical company is hiring a Validation Engineer on a contract basis.

Work Location:
Devens, MA – 100% on site

Knowledge/Skills Required/Education:

  • Specific technical skills with biopharmaceutical processing including a minimum of 5 years of experience developing and/or testing process automation system software (preferably Delta V batch). Understanding of S88 and batch processing operations required. Practical experience with large scale distributed control systems required.
  • Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
  • Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
  • Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry.
  • Knowledge of procedural batch processing automation in a Delta V environment.
  • Knowledge of a system life cycle validation techniques for automation software specification and development.
  • Familiar with construction techniques and automation system hardware installation practices.
  • Experience with dealing with recognized large automation providers (Emerson, Rockwell preferred).
  • Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts. A working understanding of lean principles is a suggested.
  • Demonstrated proficiency in project management, oral communication, and technical writing skills are required.
  • The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
  • Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
  • Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.
  • Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).


  • Leads the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System (MES)) in a highly automated biologics manufacturing facility.
  • Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).
  • Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
  • Executes and/or leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
  • Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.
  • Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
  • Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
  • Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.
  • Ensures alignment with client directives and industry guidelines on validation.
  • Duties may include internal compliance or efficiency improvement efforts within department.
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