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

Location: Maryland

Duration: 6 Months

• Overview:
  • Respond to on-demand troubleshooting requests from Manufacturing Sciences pertaining to the clients OSI PI and Kepware systems. Escalate outstanding issues to ES&T Automation and Manufacturing area management
  • Background in GMP / 21CFR Part 211 Regulations
• Specific Skills:
  • OSI PI Tools for tag creation, modifications, troubleshooting, and trend visualization.
  • OSI PI point configuration investigation
  • Kepware Clients
  • Segregated network infrastructure
  • vCenter vSphere
  • Windows Virtual Machine Admin Tools

Please have candidates with 3-15 years of experience

The Client is dedicated to making products that save lives and improve patient health worldwide. As a Senior Automation Engineer, you will design, implement, and maintain automated systems in a cGMP environment to enhance manufacturing efficiency and reliability, while collaborating with various teams to ensure compliance and operational excellence.

Understanding of Data Historian and Production Lines -Historian Systems

Vast Understanding of Automation Network - network side of automation

Design, develop, and implement automated systems, including software, hardware, and processes

Analyze existing systems, identify areas for automation, and create solutions that meet specific needs

Configure and/or manage site-level automation systems (e.g., serialization, data historian, reporting, industrial networking)

Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities, including authoring and/or reviewing IQ/OQ/PQ protocols, test execution, and authoring summary reports

Support the development of site automation standardization and/or technology master plans

Write scripts and code to automate tasks, processes, and workflows using various programming languages

Test and optimize automated systems to ensure they function correctly and efficiently

Identify and resolve issues and continuously improve system performance

Implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products

Troubleshoot and resolve issues with automated systems, ensuring they operate smoothly

Diagnose problems, implement fixes, and perform maintenance tasks

Support maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation-related PMs (e.g., backup/restore), and support of out-of-tolerance investigations related to instrument calibrations

Collaborate with other engineers, technicians, and stakeholders to develop and implement automation solutions

Effectively communicate technical information and ensure project success

Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls, and CAPAs through participation on cross-functional teams

Participate in plant engineering, maintenance, and calibration activities as needed

Required

BS in engineering/related degree or equivalent experience

8+ years of related experience; or 6 years with a master's degree, or 3 years with a PhD

Experience with a variety of PLCs, HMI hardware, and industrial sensors and applications

Controls design experience

General electrical design knowledge

Working knowledge of cGMP, GAMP5, and regulatory requirements

Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal

Preferred

Minimum of 8 years of previous work experience in a related field

Experience working with nasal spray products and devices or related drug-delivery devices

Industrial networking and server management

Experience with site-level automation systems such as: Serialization: Antares, Tracelink, Data historian: Aveva OSI PI, Reporting systems: OSI PI, MS Report Builder, SQL Development, Kepware, Matrikon, AB Factory Talk, Automated Visual Inspection

Maintenance Package Development (MPD) Lead

Location: Indiana

Duration: Jan 2026 – Dec 2027 (24 months), extendable to 36 months

Project Background: 

The objective for the Client Program is to deliver a new highly automated and state-of-the-art clinical trial manufacturing facility. The campus will have buildings for classic synthetic chemistry and monoclonal antibody production as well as areas for newer modalities including conjugates, peptides, and oligonucleotides. This campus will be comprised of multiple different buildings which include:

·     Lab/admin building

·     Warehouse

·     Central utilities building (CUB)

·     Tank farm and central corridor

·     Small Molecule building

·     Biologics building

·     Hybrid building

Maintenance Package Development (MPD) Program Objective: 

The primary goal of the MPD program is to ensure the timely development and      delivery of accurate, complete maintenance packages to Site Engineering, Maintenance, and Process Owners. The scope of MPD includes identification and entry of data needed to complete the population for all CMMS entries including Locations, Assets, Job Plans, Preventive Maintenance (PM)’s and Spare Parts. The program is comprised of these typical activities; however, this is not an exhaustive list:

·     Reconciliation of tag data on drawings, compared to Project Information Management (PIM) data.

·     Identify information required for MPD development to support project information management data, drawing, and document requirements

·     Define maintenance analysis, data, and document development activities and requirements for delivery of MPD packages

·     Define tools and templates that will be used for the delivery of the MPD information

·     Identify logical maintenance development milestones and work with P6 / schedule owner for project integration

·     Describe owner review and approval of maintenance packages

·     Identify and provide MPD status, tracking, and metric reporting requirements

·     Identify development and management strategies for package delivery

·     Ensure that data and document delivery timing is integrated with the owner’s Commissioning & qualification (C&Q) activities, i.e., calibrations.

·     Development of Location data load sheets 

·     Development of Asset data load sheets 

·     Development of Maintenance and Calibration Job Plans in GMARS 

·     Development of calibration data sheets in GMARs

·     Development of PM data load sheets 

·     Development of recommended stocking strategy to reliability engineers for stocking strategy

Role Responsibilities:

·     Oversee/Own the coordination, planning, scheduling, development, and execution of all MPD activities.

·     Utilize The Clientand contracted resources to achieve overall success

·     Ensure timely deliverable and milestones

·     Establish metrics and provide real-time assessments of deliverables to GFD PIM/Verification/MPD Lead and Project Management

·     Own communication plan and facilitation between cross discipline teams (PIM, C&Q, Maintenance, and Ops readiness) relative to roles and responsibilities, deliverables, and timing.

·     Seek alignment of scope with cross functional groups (PIM, site, project)

·     Ensure alignment with Global and Site procedures for MPD activities

·     Assist in the development, review, and approval of site-specific MPD strategy documents and procedures

Role Requirements:

·     BS Engineering (or equivalent experience).

·     10+ years of project management, engineering, maintenance or operations

·     Demonstrated leadership and people management skills.

·     Ability to lead of group of The Client employees as well as contractors.

·     Knowledge of GMP’s, regulatory requirements, and maintenance

·     Knowledge and working understanding of GMARs

·     Good written and verbal communication skills with both technical and non-technical staff.

·     Knowledge of The Client internal procedures and policies and how they apply to the development and management of maintenance packages and activities

·     Working Knowledge of Reliability Centered Maintenance (RCM) and how RCM drives maintenance tasks, intervals, etc.

Travel: 

·     No project travel time is anticipated; however, an Indiana presence is strongly preferred with a minimum of ~50% on site time.

Additional Information:

·     40 hours per work week

·     An hourly rate all-inclusive of any travel, relocation, or temporary housing expenses.

Quality System Lead. 

Under limited supervision:

·      Quality Lead for the business working with the Windchill PLM team to map out data migration for The Client Inc procedures, work instructions, parts, specification, records, etc (all quality system document types) into new system container

·      This includes overall change management process development and implementation for The Client Inc.

·      Document Control Management

·      Develops full knowledge of the The Client quality system and plans transition out of the The Client quality system into a stand-alone/hybrid quality system across Neurovascular business.

·      Lead quality system harmonization and improvement efforts, including developing quality plans/project plans and maintaining project schedules. 

·      Monitors overall quality system project, identifies issues, recommends and implements appropriate actions

·      Ensures any Quality System changes are in accordance with requirements of FDA 21 CFR Part 820, ISO13485:2016, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, , Australia TGA and other applicable regulatory standards considering the countries/regions products are marketed.

Requirements:

·      Comprehensive knowledge of ISO 13485:2016, FDA QSMR.

·      Change Management Experience

_________________________________________________________________________________________________

FROM QUALIFICATION CALL:

Key experience needed for the role is:

1) Change Mgmt exp, documentation explained and justified

2) Comprehensive exp in 13485 as well as QSMR.

Pluses would be having been a Quality Mgmt representative or having had past audit exp. They are using ETQ but she said exp with this system is not necessary.

Candidate should know how to separate the reqs from what The Client needs and what THE CLIENT was doing then maintaining compliance

They have a sister company in Ireland- she wants to harmonize some things in the QS- they'll look at CNV and Niravi... can they harmonize this procedure while doing the transition with t

Previous Client experience is ideal.

Management Rep is ideal.

Have to make sure they understand it's an execution role.... not looking for leader to tell people how to do things well or better... they need to understand design control to assess procedures.... but she's not going to change design controls.

Remote (on site every 4-8 weeks and a while and orientation)

12 months + extensions

Number of positions: 3

Client is looking for someone (not programmer or code writer) with Delta V writing executing protocols create documents and test scripts from blank templates. Will also take CQV with experience with writing documents that has experience with Delta V. Client can interview next week.

2-5 years’ experience in Commissioning and Qualification – Pharma

• 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

Location: Remote

Duration: 8–9 weeks | 40 hrs/week

Dates: Start as early as 1/26

Overview

Support a manufacturing site that recently onboarded IBM Maximo by building and refining the equipment asset tree. This role requires hands-on Maximo experience and a solid understanding of plant maintenance and equipment.

Key Responsibilities

• Build and expand detailed asset hierarchies in Maximo
• Review operating and maintenance manuals to identify equipment structure
• Configure asset records and modules within Maximo
• Validate asset data for accuracy and usability
• Collaborate regularly with onsite plant team
• Use documentation stored in SharePoint

Requirements

• Hands-on IBM Maximo experience (must be self-sufficient)
• Maintenance or plant operations background
• Experience building asset trees in a CMMS
• Familiarity with industrial equipment (conveyors, bins, rotating equipment)

Location: Remote

Duration: 8–9 weeks | 40 hrs/week

Dates: Starting 1/26

Overview

Support a post-Maximo implementation cleanup by reconciling spare parts inventory data. This role focuses on identifying, validating, and uploading accurate parts information into the CMMS.

Key Responsibilities

• Identify spare parts that are missing, misidentified, or duplicated
• Reconcile inventory data across spreadsheets, Maximo, and onsite findings
• Upload and update spare parts records in Maximo
• Partner with onsite personnel conducting physical inventory checks
• Keep data organized and ready for system entry

Requirements

• Experience with IBM Maximo (inventory/spare parts preferred)
• Understanding of maintenance spare parts and industrial equipment
• Strong attention to detail and data reconciliation skills
• Comfortable working with spreadsheets and incomplete data