Back to jobs

MES (Manufacturing Execution System) Engineer

Philadelphia, PA.

This position reports to the Manager, IT Manufacturing Systems.  The MES (Manufacturing Execution System) Engineer will utilize their expertise in Syncade MES Recipe Authoring to develop and maintain a robust, lean, and reliable Electronic Batch Record (EBR) to support Iovance’s cell therapy manufacturing process.

The MES (manufacturing execution system) Engineer will serve as a technical resource, providing operational support, performing configuration/documentation updates, and maintaining the Syncade Manufacturing Execution System (MES). 

As well as being an operational and application support resource, the role will partner with the functions (Manufacturing, Quality, MSAT, R&D) to ensure IT at Iovance is maintaining and delivering systems to meet the business requirements.

 Essential Functions and Responsibilities

  • Perform general engineering tasks related to MES, as delegated by the system owner (IT Manager), such as Recipe Authoring, Equipment Tracking configuration, administration-level configuration updates, report configuration (Crystal Reports), data mining (SQL query authoring), etc.
  • Assist team with operational activities (e.g. end-user support, break-fix) for all aspects of MES system (Electronic Batch Record/Recipe Authoring, Equipment Tracking/Workflows, Order/Inventory Management, interface to external systems/instruments, etc.) – on-call support required.
  • Act as technical resource for major MES projects (EBR authoring and deployment)
  • Knowledge of pharmaceutical business processes, Part 11 data integrity, infrastructure, architecture, and technology to support business supporting manufacturing.
  • Partner with business teams, learn business processes and drive continuous improvement initiatives to provide operational efficiencies and cost reductions.
  • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
  • Perform miscellaneous duties as assigned.

Travel

  • Travel requirements less than 10%
  • On-site at Philadelphia manufacturing facility > 80%

Required Education, Skills, and Knowledge

  • 2-4 years of hands-on experience and exposure working in biotech/pharma information technology and/or consulting for the pharmaceutical industry.
  • A minimum of 1 year of experience performing Recipe Authoring within Emerson Syncade MES.
  • Bachelor's degree required, preferably in Computer Science, Engineering, Chemical/Biomedical Engineering, or similar field of study
  • Experience in pharmaceutical and/or medical device industries.
  • Strong understanding of CRF 21 Part 11, Annex 11, cGMP, GAMP5

Preferred Education, Skills, and Knowledge

  • Experience implementing and administering MES (Emerson Syncade)
  • Familiarity with the back-end design, operation and the supporting database structure of Syncade MES is a plus.
  • Experience configuring interfaces between MES and external systems (ERP, LIMS, BMRAM, etc) and instruments (cell counters, scales, etc) is a plus
  • Experience with Iovance’s additional systems including ERP (NetSuite), Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain) is a plus.
  • Experience with Computer System Validation (CSV) is highly preferred.
  • Experience with cell and gene therapy/biologics manufacturing preferred.
  • Strong interpersonal, presentation and communication skills.
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • Can work as an effective team resource as well as independently.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required 

  • Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
  • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
  • Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
  • This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
  • Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment 

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

#LI-remote

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.  

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 


Create a Job Alert

Interested in building your career at Iovance Biotherapeutics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Iovance Biotherapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.