Onesource Regulatory Jobs in Indiana (NOW HIRING)

Role Summary

This is afull-time salaried position withProject Farma,a PerkinElmer company. The successful candidate willresidein one of Project Farma's primary markets and bewilling to travel domesticallyto meet client project requests.

Project Farma's purpose is toimprove patient lives by accelerating the delivery of life-changing therapies.Weaccomplishthis through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth byidentifyingopportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

This role contributes toorganizational success by supporting financial performance, operational efficiency, and continuous improvement, while also investing in people through mentorship, knowledge sharing, and professional development.

All team members are expected to embody Project Farma's values by beingcurious,personable, andunselfish, whilemaintaininga strong commitment to aPatient Focused and People First mindset.

TheManufacturing & Tech Ops-Manager/ Senior Managerisresponsible forleading aprojectteam and overseeing the execution of work aligned to project, client, and businessobjectives. This role balancespeopleleadership with operational accountability, including coaching, performance management, resource planning, and ensuring high-quality delivery within defined scope, timelines, and budget.This positionplays a critical role in ensuring the reliability and performance of production and support equipment in a regulated pharmaceutical manufacturing environment. This role involves executing reactive, preventive, and predictive maintenance, troubleshooting mechanical, hydraulic, pneumatic, and control systems, and supporting GMP-compliant operations.

Key Responsibilities

• Perform maintenance activities in compliance withcGMPsandSOPs.

• Assemble, disassemble, install, repair, andreplacecomponents for pharmaceutical-grade machinery and cleanroom equipment.

• Troubleshoot and resolve issues in mechanical, electrical, pneumatic, and PLC-controlled systems.

• Maintainaccuratedocumentation includingMaintenance andCalibrationRecordspercGMP standards.

• Inspect equipment for wear, irregularities, and potential failures.

• Collaborate with cross-functional teams (Quality, Engineering, Production) to ensure equipment reliability and compliance.

• Execute scheduled PMs and CMMS updates ina timelyandaccuratemanner.

• Maintain tools and workspacesin accordance withcGMP housekeeping standards.

• Adhere to OSHA, and site-specific safety protocols.

• Participate in continuous improvement initiatives and equipment reliability programs.

• Support audits and inspections by regulatory bodies and internal quality teams.

• Lead, coach, and develop a team of technical professionals to deliver highquality work aligned with project, client, and businessobjectives.

• Provide daytodaypeopleleadership, including onboarding, training, mentorship, and ongoing skills development, to build a strong and capable technical team.

• Set clear performance expectations and provide regular feedback, coaching, and guidance to support individual growth and accountability.

• Other duties as assigned.

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professionalexpertise

• Innovation & Continuous Improvement: Seeks better ways, adapts to change and championsnew ideas.

• Customer Focus & Professionalism:RepresentsPF with consistent professionalism,appropriate escalationand respect for internal stakeholders, even during high stress delivery situations

• Integrity & Humility:RepresentsPF with consistent professionalism,appropriate escalationand respect for internal stakeholders, even during high stress delivery situations

• Collaboration & Communication:RepresentsPF with consistent professionalism,appropriate escalationand respect for internal stakeholders, even during high stress delivery situations

• Project Execution: Delivers reliably, managesprioritiesand drives forhigh qualityoutcomes

• Growth Mindset: Shows openness tonew ideas,feedbackand change

Experience Required

• 7-13years of experience in mechanical maintenance within pharmaceutical, biotech, or regulated manufacturing environments.

• Strong mechanical aptitude with troubleshooting and critical thinking skills.

• Familiarity with demands of performing maintenance activities in a cGMP environment.

• Ability to interpret technical documentation and engineering drawings.

• Strong communication, organizational, and analytical skills.

• Comfortable working in confined spaces, heights, and around chemicals.

• Ability to use basic hand tools, powertoolsand meters (DVM,Ampand Ohm).

• Experience leading teams, projects,vendorsor technical workstreams.

• Travel: Willingness to travel asrequiredfor client project assignments.

Other Preferred

• Certification in First AidorCPR,

• Familiarity with ISO standards andFDAauditprocesses.

• Experience supporting equipment qualification (IQ/OQ/PQ).

• Experience with aseptic processing, HVAC systems, and utility maintenance is a plus.

• Technical diploma or degree in Mechanical Engineering or equivalent.

• Proficiencyin troubleshooting PLCs, HMIs, and automated systems.

• Skilled in using lathes, mills, grinders, and precision instruments.