Senior Process Engineer

Senior Process Engineer

RCM is seeking a Senior Process Engineer to work with a leading biotech, focusing on Autoinjector Assembly: From component feeding to final assembly. This role serves as the client's technical representative for the cartridge assembly line of an injector pen combination product, covering the full process from bulk component feeding through cartridge insertion, subassembly, final assembly, and inspection. The engineer acts on the owner's behalf — not as a vendor employee — protecting the client's interests in scope, schedule, cost, quality, and regulatory compliance across equipment suppliers, integrators, and contract manufacturers. The successful candidate will be the single point of technical accountability for how the process is specified, built, tested, validated, and handed over.

Core Responsibilities

Process definition and ownership

• Own the end-to-end process description and process flow diagram for cartridge assembly.
• Develop and maintain User Requirement Specifications (URS) for each process step and equipment cell; translate product design intent and Critical Quality Attributes into Critical Process Parameters and in-process controls.
• Lead tolerance stack-up review between component drawings and assembly process windows, and escalate design-for-assembly conflicts to the product development team before equipment design freeze.

Owner's representative duties

• Act as the client's technical authority in all interactions with equipment OEMs, systems integrators, and automation vendors. Review and challenge vendor design proposals rather than accepting them.
• Review and approve vendor deliverables: functional design specifications, mechanical and controls design reviews, HMI and recipe architecture, safety assessments, spare parts lists, and documentation packages.
• Track vendor progress against milestones, identify schedule risk early, and provide the client with an independent assessment distinct from the vendor's own reporting.
• Manage change orders and scope disputes on the client's behalf; evaluate technical merit and cost impact of vendor-proposed changes.
• Witness and disposition Factory Acceptance Testing and Site Acceptance Testing; own the punch list through closure.

Commissioning, qualification, and validation

• Author or review Commissioning and Qualification strategy, IQ/OQ/PQ protocols, and process validation plans consistent with the client's Validation Master Plan.
• Design and execute process characterization studies, DOEs, and worst-case challenge runs to establish proven acceptable ranges for parameters such as insertion force, crimp height and force, weld energy and collapse distance, and torque.
• Define and qualify in-process inspection methods, including vision systems, force-displacement signature monitoring, and leak or container closure integrity testing; support Gage R&R and measurement system analysis.
• Support the overall combination product control strategy and provide technical content for regulatory submissions as requested.

Ramp-up and transfer

• Lead troubleshooting and root cause analysis during commissioning and early production: feeder jams, misfeeds, orientation faults, component damage, false rejects, and cycle-time losses.
• Establish baseline OEE, first-pass yield, and scrap targets; drive structured improvement to meet contractual performance guarantees.
• Ensure a complete handover to the client's operations team: SOPs, batch record content, changeover procedures, preventive maintenance plans, training materials, and as-built documentation.

Qualifications:

• 5+ years in high-speed automated assembly of medical devices, combination products, or precision components; at least 3 years directly on drug-delivery devices (pen injectors, autoinjectors, prefilled syringes, on-body injectors) strongly preferred.
• Demonstrated experience writing URS documents and managing automation equipment suppliers from concept through SAT.
• Working knowledge of cGMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, and ISO 11608 as they apply to needle-based injection systems.
• Hands-on familiarity with vibratory and centrifugal feeding, pick-and-place, servo-driven insertion, vision inspection, and reject handling.
• Strong statistical toolkit: capability analysis, DOE, MSA, SPC.
• Ability to read and interpret GD&T drawings and to evaluate component variation effects on assembly performance.

Education & Certifications:

• Bachelor's degree in Mechanical, Manufacturing, Biomedical, or Chemical Engineering, or equivalent.

Equal Opportunity Employer: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. About RCM: RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.