Job Title: Senior Process Engineer
Location: Indianapolis, IN 46268
Duration: 12 months (temp-to-permanent)

Description:
The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility. Flexible to support second shift when needed to ensure the project's critical timeline is maintained.

Major Accountability:

• Guide and supervise onsite installation and commissioning activities of equipment/system
• Install subsystems owned by client in production line
• Implement equipment optimizations and modifications
• Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
• Lead complex root cause investigations
• Performs change assessments
• Preparing, scheduling, coordinating, and monitoring of assigned engineering projects.
• Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.
• Second line escalation in case of equipment failures
• Driving continuous improvement from an asset perspective
• Reducing safety risks through simplification and error proofing machines
• Improving equipment reliability through equipment design modifications
• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
• Set-up maintenance for new equipment (incl. spare part needs).
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals.
• Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.
• Perform GMP risk assessments (incl. Sensors SRA).
• Independently manage and resolve deviations on equipment and systems.
• Support internal and external audits.
• Provide technical trouble shooting during Startup, PQ and validation activities
• Develop periodic requalification plan
• Execute periodic requalification plan
• Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
• Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
• Write/revise accurate engineering documents for various production system.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning activities as required.
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs
• Complete and provide accurate documentation, as required in cGMP operations.
• Use of CMMS system for documentation of relevant work.
• Other related duties as assigned.?

Minimum Requirements:

• Bachelor’s Degree in Engineering or related field is required
• 5+ years of relevant experience in a GMP environment is required
• Previous experience in the pharmaceutical industry is required.
• Pharmaceutical aseptic filling experience is preferred
• Vendor management experience is a plus
• Knowledge/experience in automation or computer system validation (CSV) is a plus
• Experience managing projects is preferred

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $80.00/hr.