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Manufacturing Execution Systems Engineer

TekWissen LLC

  • Portsmouth, NH
  • 5 days ago
  • $50–$60

Highlights

Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Numbers & Facts

LocationPortsmouth, NH
IndustryComputer/IT Services
Salary$50–$60
Company Size100 to 499 employees
Year Founded2009
Websitehttp://www.tekwissen.com/

Description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Manufacturing Execution Systems Engineer
Location: Portsmouth, NH 03801
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 1st Shift

Summary

Responsible for overseeing and executing MES validation activities related to the gLIMS implementation. This role ensures that all validation deliverables are completed on time and in full compliance with global guidelines, regulatory requirements, and quality standards. The position supports requirements gathering, testing, integration, and implementation of Manufacturing Execution Systems (MES) in conjunction with gLIMS and operates with a moderate level of supervision and autonomy.

Responsibilities

  • Lead gLIMS-MES interface validation activities and ensure timely completion, review, and approval of validation deliverables and documentation.
  • Collaborate with the Site Change Manager and Automation SME to update or replace impacted MES/LIMS SOPs and processes in alignment with global and local standards.
  • Work closely with gLIMS/MES leads, system users, and process owners to develop and revise MES recipes supporting gLIMS interfacing.
  • Configure production recipes using object libraries as required.
  • Execute validation test scripts, including test design, execution, simulation, and documentation activities, under the guidance of the supervisor or Validation SME.
  • Ensure all validation activities comply with regulatory, quality, and cGMP requirements.
  • Support cross-functional teams during MES integration and implementation activities.
  • Perform additional duties and project activities as assigned.

Required Skills

  • Bachelor's degree in a STEM field or Computer Science with relevant industry experience.
  • 5 10 years of experience in Automation, Validation, Quality Control, Pharmaceutical, or Biotech environments.
  • Should have hands on experience in systems integration role, connecting Syncade to other software tools like LabVantage LIMS (referred to as gLIMS) and or other systems.
  • Hands-on experience with MES, LIMS, or comparable manufacturing and laboratory systems.
  • Strong knowledge of Computerized System Validation (CSV) methodologies, validation templates, protocols, and SOPs.
  • Familiarity with GMP/cGMP regulations, quality systems, and regulatory compliance requirements.
  • Experience with deviations, change controls, CAPAs, OTNs, and TrackWise or similar quality management systems.
  • Understanding of process, equipment, cleaning, and computer system validation activities.
  • Proficiency with Microsoft Project, Word, Excel, and PowerPoint.
  • Strong project management, planning, organization, communication, and cross-functional collaboration skills.
  • Ability to manage multiple priorities and medium-to-large validation projects within established timelines.
  • Experience supporting gLIMS implementations or MES/LIMS integration projects.
  • Background in pharmaceutical manufacturing operations, quality systems, or automation projects.
  • Experience reviewing and approving validation protocols, test scripts, and summary reports.
  • Regulated pharmaceutical / biotechnology manufacturing environment
  • Cross-functional collaboration with Automation, Quality, Manufacturing, Validation, and IT teams
  • Combination of independent work and collaborative project execution

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

About Company

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



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