[awsmjobs]
2-5 years’ experience in starting up Utility systems – Pharma / Oil & Gas
- Be part of a team of engineers to develop operation verification test scripts.
- Help develop Startup Logic and handover prioritization.
- Assist in the development of startup activities such as flushing / pressure testing plans and system livening.
- Understands generic LOTO procedures.
- Has experience with execution on installation verification and operation verification execution.
- Has exposure to working with vendors.
Additional: DeltaV experience, Kneat experience, PQ experience
We are looking for a Clean Validation Engineer who has experience starting up, validating water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems. Ideal candidates would have experience in the full Cleaning Validation lifecycle including specification review, vendor document review, document field verification, commissioning document drafting, commissioning execution, and summary report drafting. Sample testing, protocol writing. 10 yrs or less experience will suffice. Must be able to work in a fast pace environment. Greenfield experience.
-Kneat
-CIP/COP cleaning Validation
Nice to have: Cleaning Validation Technical Writing along with technical data reviewing.
Additional resource for small parts SME needed
Location: Maryland
Duration: 6 Months
Start:End of September
Current issue: people are not lightening the load- supposedly mid level, but they can't do anything independently even after being given time
SCADA system: Rockwell( biggest), Ignition
OSI PI Historian- data management
Industrial network- IO link, Ethernet communications, DeviceNet
various software with their standalone equipment
most processes are under 2000L bioreactors (so mid - level mfg)
*They do both continuous and batch processing
*Need to be able to Gown-in, specifically an ISO 7 cleanroom
*GMP focus and change management experience
*Awareness of scheduling impact on production based on equipment's being brought down.
Duties: start off with developing URS based off of end users, talk to quality department (determine and understand impact on existing systems and how to capture changes), then more of the technical part would need to be done... prepare this phase/ equipment module, landing module I/O input from PLC or equipment and make it do X.
Syncade MES Automation Support Engineer
Project Overview
The Client, is constructing a large-scale pharmaceutical manufacturing facility in Holly Springs, NC. The facility shall provide a world class Contract Development and Manufacturing Organization (CDMO) with capabilities to provide end to end services for Pre-Clinical, Early & Late Phase Clinical, and Commercial Production. The site has significant room to expand and grow in the future. The initial Phase 1 includes two Drug Substance Manufacturing facilities (DSM 1 & DSM 2), a Central Utilities Building (CUB), Tank Farm, a Drug Product Filling and Finished Goods Packaging Facility (DPFG), Warehouse, and Lab/Admin building. These buildings shall be connected by a large, centralized corridor (Spine).
A DSM, containing a “4-pack” of 20,000L bioreactors, will have a single Production Line consisting of two seed trains and a single purification suite. The second DSM will be an identical copy of the first. The DSM buildings have process functions that interface with other buildings, such as the Central Utilities Building (CUB) and Warehouse.
The process and equipment design will heavily leverage the design of a current expansion project at the Denmark facility in Hillerød, DK. It is anticipated that the P&IDs for most areas will require minimal, if any, technical updates for the project. URSs for process equipment and PRSs defining process automation functionality will be provided by the expansion project as a basis for the design.
Scope of Services
The following scope will be provided by the Syncade MES Automation Support Engineer:
· Support the design and implementation of an Emerson Syncade Manufacturing Execution System to support our vision of paperless manufacturing with full ERP/MES/DCS integration and enforced workflows for a CDMO facility.
· Attend regularly scheduled project status meetings with MES Team.
· Provide design review and input on system requirements and lifecycle documentation related to the following MES functions:
o Order Management, Material Management
o Bill of X (Materials, Parameters, Transactions)
o Workflow Execution
o Electronic Batch Record (EBR)
o Quality Review Manager (QRM)
o Weigh & Dispense
· Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, QA, and others as needed.
· Responsible for translation of system requirements into test protocols
· Responsible for testing of MES project, which includes infrastructure setup, software installation, recipe development, and User Acceptance Testing (UAT) with users.
· The team provides 24/7 On Call Support Coverage
Additional Details
· 1+ years’ experience configuring and implementing Manufacturing Execution Systems
· 1+ years’ direct Emerson Syncade experience is required
· Experience working on and setting up Zebra Label Printers (Only 1 person out of the 3, would require gowning training)
· Experience debugging configuration items within the Emerson Syncade application
· Experience in a cGMP facility or working with FDA regulations, S88 batch model, ISA 95, GAMP5 and 21 CFR Part 11 (ERES) is required
· Programming skills, preferably within VB Script, XML/XPATH/XSLT and SQL/TSQL is a plus
· Knowledge with Emerson DeltaV, OSIsoft PI, and InfoBatch is a plus, but not required
· Excellent oral and written communications skills and fluency in English
· Provide rate sheet applicable for the duration of this project
· It is expected that this role will require 40hrs/wk, in a hybrid model (3-4 days onsite/week). This resource will report to the Associate Manager – Automation, Manufacturing Applications.
· Key Dates
· Scope of Work developed – September 18, 2025
· Project Award – October 24, 2025
· Project Start – November 3, 2025
· Project Completion –June 30, 2026
BMS Lead Wonderware Engineer Backfill
BMS Wonderware Engineer
Start Date: 10/20
Duration: 12 months +
Location: Raleigh NC
The gist of the position is pharmaceutical BMS lead. General highlights I am looking for:
- Person who will have PM Experience, helping him design RFP to contractors.
- Won ‘t be doing programming or coding
- PM experience and knowledge of the programming that can take the coordinator effort on the manager plate
- Coodinate handover from Integrator to the client
- Ability to lead teams of resources, including external resources such as systems integrators
- Hands on expertise in Siemens, Rockwell, and Wonderware
- Experience with BMS equipment such as chillers, boilers, AHUs (in order to guide integrators).
- Siemens TIA Portal Experience
Basically the role is to help manage and drive the additional data from DSM3/4 and some additions to the CUB to the existing BMS/VDS systems (this includes the Wonderware SCADA, TopView, ICE, etc). They will help me scope and define the system integrator RFP and then lead that team to execute that work.
Location: Maryland
Duration: 6 Months
Start:End of September
Current issue: people are not lightening the load- supposedly mid level, but they can't do anything independently even after being given time
SCADA system: Rockwell( biggest), Ignition
OSI PI Historian- data management
Industrial network- IO link, Ethernet communications, DeviceNet
various software with their standalone equipment
most processes are under 2000L bioreactors (so mid - level mfg)
*They do both continuous and batch processing
*Need to be able to Gown-in, specifically an ISO 7 cleanroom
*GMP focus and change management experience
*Awareness of scheduling impact on production based on equipment's being brought down.
Duties: start off with developing URS based off of end users, talk to quality department (determine and understand impact on existing systems and how to capture changes), then more of the technical part would need to be done... prepare this phase/ equipment module, landing module I/O input from PLC or equipment and make it do X.
Title: Process Engineer, Down Stream Buffer Prep and Hold
LOA: 12 months
Location: NC
Main Responsibilities:
This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Galaxy project, the phase 1 project in Holly Springs, NC. The assignment is to assume the Responsible Engineer role for Down Stream Process Engineering, Buffer Prep and Hold unit operations.
As the site prepares for commercial operations starting in 2026 the position is to support the final CQV activities and manufacturing operations startup activities centered around the Buffer Prep and Buffer Hold unit operations of Mixing, Transfer and Hold of Buffers. Secondary responsibility includes supporting commercial operations, technology transfers, and small capital projects.
Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations to ensure compliance with all safety, regulatory, and engineering requirements. This role adheres to product and customer requirements and work towards optimizing plant efficiency and profitability.
The Buffer Prep and Hold Process Engineer shall have specific unit operations experience in a mAB (monoclonal antibodies) production to include set up, operations, and troubleshooting.
· Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
· Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
· Develops and aligns basic plans and provides mitigations, as needed
· Provides direction to detailed design activities in partnership with the EPCM provider
· Writes User Requirements Specifications (URSs)
· Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
· Supports Commissioning Qualification and Validation (CQV), and start-up activities
· Serves as on-call support for process equipment
· Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
· Performs system impact assessments and quality risk assessments for process equipment
· Performs technology transfer (TT) activities related to process equipment
· Supports execution of Good Manufacturing Practices (GMP) runs
· Provides technical support for root cause analysis (RCA) and process deviation investigations
· Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
· Makes decisions regarding technical risk assessments for new manufacturing equipment
· Provides on-floor manufacturing support for equipment issues
· Provides process equipment training and consultation on topics within assigned area
· Supports continuous improvement projects in partnership with Maintenance and Manufacturing
· Cross-trains on multiple unit operations to assist team with achieving deliverables
· Collaborates with other departments, such as Quality, Manufacturing, Maintenance, Validation, and Safety.
· Other duties, as assigned
Experience and software:
· 5 years of Engineering experience
· Experience in a Life Science or other regulated industry
Prior experience working in a cGMP environment or other highly regulated industry
· Ability to develop effective working relationships internally and externally
· Effective communication, both written and oral
· Strong problem-solving skills
· Project Management skills
· Ability to effectively present information to others
· Ability to provide standard professional advice and create reports and analyses for review
Excel, Word, Powerpoint, CMMS, Bluebeam, Kneat, Trackwise
Title: Process Engineer- Down Stream, Initial Purification
LOA: 12 months
Location: NC
Main Responsibilities:
This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Galaxy project, the phase 1 project in Holly Springs, NC. The assignment is to assume the Responsible Engineer role for Down Stream Process Engineering, Initial Purification unit operations.
As the site prepares for commercial operations starting in 2026 the position is to support the final CQV activities and manufacturing operations startup activities centered around the Initial Purification unit operations of LPC (Chromotography), Downstream Filtration, Product Hold, and Buffer Hold. Secondary responsibility includes supporting commercial operations, technology transfers, and small capital projects.
Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations to ensure compliance with all safety, regulatory, and engineering requirements. This role adheres to product and customer requirements and work towards optimizing plant efficiency and profitability.
The Initial Purification Process Engineer shall have specific unit operations experience in a mAB (monoclonal antibodies) production to include set up, operations, and troubleshooting.
· Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
· Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
· Develops and aligns basic plans and provides mitigations, as needed
· Provides direction to detailed design activities in partnership with the EPCM provider
· Writes User Requirements Specifications (URSs)
· Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
· Supports Commissioning Qualification and Validation (CQV), and start-up activities
· Serves as on-call support for process equipment
· Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
· Performs system impact assessments and quality risk assessments for process equipment
· Performs technology transfer (TT) activities related to process equipment
· Supports execution of Good Manufacturing Practices (GMP) runs
· Provides technical support for root cause analysis (RCA) and process deviation investigations
· Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
· Makes decisions regarding technical risk assessments for new manufacturing equipment
· Provides on-floor manufacturing support for equipment issues
· Provides process equipment training and consultation on topics within assigned area
· Supports continuous improvement projects in partnership with Maintenance and Manufacturing
· Cross-trains on multiple unit operations to assist team with achieving deliverables
· Collaborates with other departments, such as Quality, Manufacturing, Maintenance, Validation, and Safety.
· Other duties, as assigned
Experience and Systems:
· 5 years of Engineering experience
· Experience in a Life Science or other regulated industry
Prior experience working in a cGMP environment or other highly regulated industry
· Ability to develop effective working relationships internally and externally
· Effective communication, both written and oral
· Strong problem-solving skills
· Project Management skills
· Ability to effectively present information to others
· Ability to provide standard professional advice and create reports and analyses for review
Excel, Word, Powerpoint, CMMS, Bluebeam, Kneat, Trackwise