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MES Validation Engineer - Hybrid Remote

Non-Headquarters

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

VALIDATION ENGINEER - MES - Hybrid Remote

(AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY SOLUTIONS)

Our new opportunity is 50% remote for our client, a new biopharma organization. Our client is heavily focused on cloud technology, including their MES (manufacturing execution system). You will join a small team that is already in place. It would be beneficial to have some experience with the Kneat electronic validation system.

Valpro is looking to identify top tier talent in the areas of automation and computer systems validation and system life cycle management.  We are motivated to identify those that share our passion and can mirror the level of energy we put into ensuring that we remain on the cutting edge of the life sciences industry.

We are looking for tech savvy professionals with a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical environments.  Due to our unique approach in meeting the demands of our customers, we are pursuing both individuals that can join our team long term as well as SMEs (subject matter experts) that would like to join us on a consulting basis.

RESPONSIBILITIES:

  • This role supports the execution of small projects or portions of larger projects.
  • Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures.
  • Conduct risks assessments and participate in Quality/Regulatory audits.
  • Develops and executes qualification protocols and final summary reports and may participate in commissioning activities.

SKILLS AND EXPERIENCE:

  • 3+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and/or Syncade experience is highly preferred)
  • Manufacturing Execution System (MES) experience
  • Experience with automation, commissioning, qualification or operations in a cGMP environment.
  • Direct experience developing validation protocols and execution of protocols.
  • Knowledge of current industry standards such as GAMP5 and ASTM E2500.
  • Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
  • Excellent client communication skills.

PREFERRED:

  • Exposure to Kneat or ValGenesis 

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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