Engineer III, Process Engineering

job summary:
The candidate in this role will play a pivotal part in enhancing and leading our cutting-edge manufacturing processes and will serve as either a technical lead for capital projects or for GMP manufacturing process equipment.. This role will focus on reducing manufacturing events, minimizing user interventions, and enhancing product quality and safety standards. The role involves direct engineering support, troubleshooting, and continuous improvement initiatives, ensuring operability and reliability of the equipment. The person in this position will collaborate closely with MS&T, Facilities, Validation, and equipment End Users to ensure projects are executed efficiently and effectively, meeting objectives and timelines. Their expertise will be crucial in optimizing production capabilities and ensuring the seamless integration of new technologies and methods in manufacturing operations. The ideal candidate will thrive in a fast-paced, dynamic, and innovative environment.

location: Norwood, Massachusetts
job type: Contract
salary: $70.00 - 78.06 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:

• Provide direct engineering support and subject matter expertise for process equipment including Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, Component Prep Equipment, and more.
• Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.
• Drive results by owning and completing medium to large-sized projects with challenging timelines and minimal support from their manager.
• Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment.
• Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, own Corrective/Preventative Actions and associated Change Controls.
• Own and maintain process equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows).
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
• Meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines.
• Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.
• Provide guidance and training on new processes, equipment, and troubleshooting techniques.
• Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.
• Ensure all manufacturing activities comply with health, safety, and environmental regulations.
• Support the Process Engineering On-call team with troubleshooting guidelines and investigation.
• Assist in the setup/changeover of manufacturing systems and processes.
• Perform operational assessments to ensure procedures and tools are in place.
• Participate in internal and external audits, addressing any findings, and implementing any corrective actions.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

qualifications:
Required

• BS. or M.S. in Chemical or Mechanical Engineering or equivalentExperience: Minimum 5 years relevant experience in Facilities, Engineering, or Operations

Preferred

• Experience in a GMP environment is preferred.
• Self-directed with effective analytical and problem-solving skills.
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
• Must be able use their technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
• Must be able to find true root cause and utilize strong decision-making skills to determine appropriate path forward for complex problems.
• Excellent interpersonal and communication skills (verbal and written) are required.
• Expecting to be able to present own work to peers and cross-functional managers and influence leadership decisions.
• Technical writing skills required.Demonstrated ability to manage own time and deliver to program timelines.
• Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.
• Familiarity with Microsoft Office Suite is required, and basic statistical analysis techniques are preferred.

skills: Process Engineering, SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.