Manufacturing Execution System Engineer
Planet Pharma, Philadelphia, PA, United States
Manufacturing Execution System (MES) Engineer
Brand new/hot one!
Base is 105-118K
Must have (critical for this role) – looking for Syncade MES experience (this is an absolute must have) - MES (Emerson Syncade). They have had a handful of applicants but none have had this experience.
Covid – vax not required
Fullly onsite
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 (Equipment Tracking/Workflows, Order/Inventory Management, interface to ERP, etc.) – on-call support required.
- Act as technical resource for major MES projects (upgrade/migration, equipment state tracking, electronic batch record).
- 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.
Travel and on-site requirement's
- Travel requirements less than 10%
- On-site at Philadelphia manufacturing facility > 80%
Required Education, Skills, and Knowledge
- 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.
Preferred Education, Skills, and Knowledge
- At least 2-4 years of hands-on experience and exposure working in biotech/pharma information technology.
- 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 with 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 manufacturing preferred.
- Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP.
- 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 accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request 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 operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
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.