Specialist, Engineering – Automation (Onsite)

Job Description

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway New Jersey includes a cutting-edge drug product cGMP clinical supply manufacturing facility known as FLEx Non-Sterile. The FLEx facility supports the formulation and filling of clinical stability and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products including critical program needs related to new products undergoing process development new products undergoing scale-up launch and transfer to the supply network and existing commercial products undergoing process optimization.

The Specialist Automation Engineering supports clinical manufacturing automation systems at the Rahway FLEx Center in Rahway NJ with a focus on non-sterile manufacturing operations. This role provides hands-on support for validated automation and OT/IT systems used in clinical and development manufacturing including troubleshooting system maintenance change control and documentation. The position works closely with Manufacturing Quality IT and engineering partners to help ensure reliable compliant operation of automation systems in a GMP environment.

This is an onsite role that may require occasional off-shift or weekend support based on manufacturing needs.

Primary Responsibilities

• Support automation systems used in clinical manufacturing by maintaining them in a validated compliant state in accordance with cGMP safety data integrity and cybersecurity requirements.

• Provide on-floor and technical support for manufacturing operations including troubleshooting automation controls instrumentation electrical and software issues.

• Assist with root cause analysis investigations CAPAs and corrective actions related to automation and OT/IT systems.

• Support system changes through change control including documentation impact assessments implementation support and testing.

• Assist with commissioning qualification and validation activities for new or modified automation systems and equipment.

• Maintain accurate and inspection-ready documentation including SOPs equipment records drawings configurations and maintenance/support documents.

• Support automation-related reporting trending and basic visualization tools using historian or SCADA data to help monitor system performance and reliability.

• Work with divisional and enterprise IT infrastructure Quality Manufacturing and external vendors to support automation system reliability and compliance.

• Participate in audits inspections and site support activities as needed.

• Support automation lifecycle activities such as periodic reviews backups patching user access administration and obsolescence remediation under direction.

• Contribute to continuous improvement efforts focused on system stability reliability and supportability.

• Provide support for capital projects as a site automation representative with limited scope focused on implementation support testing and system readiness.

Education Requirement

• Bachelors degree in Engineering Science Information Technology or a related field

• Minimum of 2 years of experience in process automation or a related technical area

Required Experience and Skills

• Strong understanding of cGMP quality systems safety data integrity and validation principles for automation and computer systems

• Hands-on experience supporting validated automation systems in a regulated environment

• Experience with change control troubleshooting investigations and documentation support

• Working knowledge of PLC/SCADA systems and industrial networking fundamentals

• Ability to troubleshoot across controls instrumentation electrical software and OT/IT layers

• Strong interpersonal communication and technical writing skills

• Demonstrated problem-solving skills and a continuous improvement mindset

• Ability to work collaboratively across functions and support multiple priorities in a fast-paced environment

Preferred Experience and Skills

• Experience with Allen-Bradley and/or Siemens PLCs

• Experience with SCADA platforms such as iFix WinCC OA or Ignition

• Familiarity with industrial communication protocols such as OPC Ethernet/IP PROFINET Profibus DeviceNet or AS-i

• Exposure to automation reporting historians databases or basic scripting

• Experience in pharmaceutical manufacturing or other regulated manufacturing environments

• Experience supporting qualification or validation documentation

• Exposure to electronic quality or validation systems

• Experience supporting audits SOPs or controlled documentation

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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