[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.
Our client is looking for an Intermediate or senior level PM. The ideal candidate needs Pharmaceutical experience with process equipment or utility infrastructure. The right resource needs to be on site 5 days a week on site.
Lead Engineer: HVAC: Field Lead
Duration: 12 + months
Location: Indiana
NO REMOTE
This individual will need to have an extensive amount of experience and years in the industry and position. They will be highly knowledgeable in all aspects of commercial HVAC systems as it pertains to Pharma. Semiconductor and other closely related industries may be acceptable.
Pharma experience will be highly preferred due to the nature of this project. Also, a well-rounded understanding of documentation as it concerns both cGMP and Non-GMP, Non-GMP will tie into GMP at boundary points so they will need to be able to manage this in the field in all aspects including documentation. They must know design, documentation and how to manage workloads, multitask negotiate work between vendors and schedulers so to ensure time limes are met.
This is a full 100 percent on site position, there is no remote work for this site. Also, this individual may have some long days including weekend work. This person will be handling multiple vendors while reports into the C&Q team.
This scope of work is to provide automation engineering services for Building A Suite AB Vax Project Autoclaves qualification project on following tasks:
- Vendor software specification review
- PLC modification (2)
- SCADA/MCS screen development
- MCS report development
- SQL/OSI PI database update.
- Functional Specification, Configuration specification, SOP, DI assessment development
- Vendor FAT and site installation support
- Drawings update
- System commissioning and operational qualification support
- Post OQ hypercare as needed
Job description: ROLE RESPONSIBILITIES
· Lead and manager all Master Data initiatives to ensure high-quality data management practices across the organization.
· Collaborate with IT, commercial, and operational teams to define data requirements and establish data quality metrics.
· Oversee data lifecycle management, including data creation, maintenance and deletion processes.
· Conduct regular audits and assessments of master data quality, identifying areas for improvement and implementing corrective actions.
· Manages the LIMS System(s), AMPS, Data Tables
· Site SME (subject matter expert) for Master Data Systems
· Manages Change Controls for Master Data Systems while providing expertise in supporting, preparing, reviewing, approving and implementing site changes and enhancements.
· Manage troubleshooting expertise, support and resolution for all Master Data activities, Operations, Supply Chain and Quality Support
· Develop, implement and maintain departmental SOPs
· Manage and Optimize Master Data for Quality operations through cross-functional support groups
· Oversee regular communication with Quality System, Manufacturing and Supply Chain end users to analyze their processes and needs and employ comprehensive knowledge to assist in decision making
· Manage hands-on, individual and group training(s) as needed for all user levels and maintain training modules/protocols/walk-through guides accordingly for the entire site.
· Participate in agency inspections, as directed
· Mentor and develop team members, fostering culture of data stewardship and accountability
BASIC QUALIFICATIONS
· BS in chemistry, physical science, computer science or relevant experience and certifications
· Possess at least 6 years of Quality Application experience
· Understanding of cGMP, cGxP, and 21 CFR part 11 for validated electronic data systems
· Excellent knowledge of Microsoft Office
· Excellent project management and organization skills
· Excellent oral, written, communication, presentation and interpersonal skills
· Demonstrated knowledge of and experience with Validation and system life cycle methodology.
· Experience with data analysis (creation of trending reports/metrics).
· Skills and experience working in culturally diverse, multi-disciplined work groups with the ability to manage multiple priorities and be self-directed in a fast paced environment.
· Previous experience in Applications and Systems administration in a pharmaceutical lab environment.
PREFERRED QUALIFICATIONS
· Preferred experience in Quality Systems
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.
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.