Job Description Job 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.

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We're founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.

TekWissen is an equal opportunity employer supporting workplace diversity.

TekWissen LLC

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Manufacturing Execution Systems Engineer