Senior Engineer, Commercial Technical Operations

Keenova Therapeutics plc; United States; Hybride; USD 80 000 - 129 000; Plein temps

Résumé du poste

Keenova Therapeutics plc seeks a Senior Engineer, Commercial Technical Operations to provide hands-on technical support for sterile drug product manufacturing across Keenova’s external network. The role focuses on aseptic filling, lyophilization, and container closure integrity, interfacing with CMOs for reliable supply and compliant execution.

This hybrid role in Philadelphia includes travel to CMOs and requires governance of investigations, CAPAs, change control, and process improvements while

Qualifications

• Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or related field.
• 7+ years direct hands-on sterile drug product manufacturing in a cGMP environment.
• Experience supporting aseptic filling for vials and/or prefilled syringes.
• Knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring.
• Knowledge of 21 CFR 210/211, USP guidance, EU GMP Annex 1.
• Lean Six Sigma (Green Belt or higher) preferred.
• Experience with external manufacturing sites, tech transfer, validation, CAPA, change control.
• Parenteral packaging and assembly experience preferred.
• Ability to travel to CMOs.

Responsabilités

• Provide direct technical oversight and on-site support for commercial sterile drug product manufacturing at CMOs.
• Support aseptic filling operations for injectable presentations, including manufacturing readiness, batch execution, process monitoring, troubleshooting, and post-batch review.
• Apply SME in aseptic processing, cleanroom behavior, environmental controls, and EU GMP Annex 1 expectations.
• Support lyophilization and terminal sterilization processes, including cycle execution and lifecycle improvement.
• Lead or support technical investigations, deviation and CAPA development, root-cause analysis, and change control.
• Develop and improve contamination control strategies with QA, Manufacturing, Microbiology, Engineering, and CMOs.
• Provide technical support for container closure systems and CCIT, including assessments and investigations.
• Support technology transfer, process validation, CPP, and manufacturing process improvements for sterile products.
• Provide technical input for drug-device interfaces, packaging, and device assembly.
• Author/review/approve technical docs and governance materials.
• Apply Lean/Six Sigma to improve robustness, throughput, and cost effectiveness.
• Provide input to batch records and SOPs, risk assessments, and CMO governance materials.
• Build relationships with external partners and internal stakeholders; communicate risks clearly.
• Maintain knowledge of regulatory expectations for sterile manufacturing and translate into controls.

Connaissances

Aseptic filling

Lyophilization

Terminal sterilization

Contamination control

CCIT

Process validation

CAPA investigations

Technology transfer

Lean Six Sigma

Regulatory knowledge

CMO collaboration

Formation

Bachelor’s degree in pharmaceutical sciences/engineering/biotechnology

Description du poste

Job Title Senior Engineer, Commercial Technical Operations Requisition JR000016028 Senior Engineer, Commercial Technical Operations (Open)

Location Philadelphia, PA Additional Locations

Job Description Summary

The Senior Engineer, Commercial Technical Operations provides hands‑on technical support and oversight for sterile drug product manufacturing across Keenova’s external manufacturing network. The role applies direct manufacturing experience in aseptic filling of vial and prefilled syringe presentations, with additional expertise in lyophilization, terminal sterilization, contamination control, and container closure integrity. The specialist serves as a practical interface between Keenova and contract manufacturing partners, supporting reliable supply, compliant execution, investigations, process and lifecycle improvements, packaging, and combination product assembly. This is a hybrid role based in the Philadelphia, Pennsylvania area, with regular travel to contract manufacturing sites, including but not limited to, locations in Washington State and Baltimore, Maryland.

Job Description Key Responsibilities

• Provide direct technical oversight and on-site support for commercial sterile drug product manufacturing at contract manufacturing organizations (CMOs).
• Support aseptic filling operations for injectable presentations, including manufacturing readiness, batch execution, process monitoring, troubleshooting, and post-batch review.
• Apply subject matter expertise in aseptic processing, cleanroom behavior, environmental and process controls, and EU GMP Annex 1 expectations.
• Support lyophilization and terminal sterilization processes, including cycle execution, performance monitoring, technical assessment, and lifecycle improvement.
• Lead or support technical investigations, deviation and CAPA development, root‑cause analysis, change control, and implementation of sustainable corrective actions.
• Develop, maintain, and improve contamination control strategies in partnership with Quality, Manufacturing, Microbiology, Engineering, and CMO teams.
• Provide technical support for container closure systems and container closure integrity testing (CCIT), including assessment of manufacturing or component changes and investigation of integrity‑related issues.
• Support technology transfer, process validation, continued process verification, process capability assessment, and manufacturing process improvements for sterile drug products.
• Provide technical support for combination products and self‑injectable devices, including drug‑device interface considerations, secondary or parenteral product packaging, device assembly, and associated manufacturing investigations and changes.
• Author, review or approve technical assessments, protocols, reports, investigation summaries, risk assessments, standard operating procedures, batch record changes, technical agreements and CMO governance materials.
• Apply operational excellence methods, including Lean and Six Sigma tools, to improve process robustness, compliance, throughput, right‑first‑time performance, and cost effectiveness.
• Provide technical input to batch records, standard operating procedures, protocols, reports, risk assessments, technical agreements, and CMO governance materials.
• Build effective working relationships with external manufacturing partners and internal stakeholders, communicate technical risks clearly, and elevate issues that may affect quality, compliance, supply, or patient use.
• Maintain current knowledge of relevant regulatory and industry expectations for sterile manufacturing and translate those expectations into practical manufacturing controls and improvements.

Qualifications: Education / Experience / Skills

• Bachelor’s degree in pharmaceutical sciences, engineering, chemical engineering, biotechnology, or a related scientific or technical discipline required; advanced degree preferred.
• Minimum of seven years of direct, hands‑on experience in sterile drug product manufacturing within a cGMP‑regulated pharmaceutical or biopharmaceutical environment required.
• Demonstrated experience supporting aseptic filling operations for vials and/or prefilled syringes required; experience with both presentations preferred.
• Working knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring interfaces, sterilization. and EU GMP Annex 1 required.
• Working knowledge of appropriate regulations including 21 CRF 210 & 211, applicable USP guidance’s, EU GMP Annex 1 required.
• Knowledge of 21 CFR Part 4 & 820 an advantage.
• Experience with one or more of the following is strongly preferred: lyophilization, terminal sterilization, CCIT, manual visual inspection, combination products, or self‑injectable device assembly.
• Experience supporting external or contract manufacturing sites, technology transfer, validation, continued process verification, investigations, CAPA, and change control preferred.
• Experience in parenteral product packaging and assembly operations preferred.
• Working knowledge of risk‑management and structured problem‑solving tools, with demonstrated use of Lean and/or Six Sigma methods required; Green Belt or higher certification preferred.
• Ability to interpret manufacturing data, identify process trends, assess technical risk, and convert findings into clear, executable actions.
• Excellent written and verbal communication skills, sound technical judgment, and the ability to influence and collaborate across a matrix organization and with external partners.
• Ability to work independently in a remote environment, manage multiple priorities, and travel regularly to CMO locations.

Organizational Relationship/Scope

Reports to Director, Commercial Technical Operations This role is as an individual contributor within Technical Operations. The Senior Engineer works closely with Quality, Regulatory Affairs, Supply Chain, Engineering, External Manufacturing, and other portfolio or project teams. The role has no direct reports unless otherwise assigned but is expected to provide technical leadership and influence across matrix teams. Externally, the role is a key technical contact for CMO manufacturing, quality, engineering, validation, microbiology, packaging, and project teams. The role supports routine site engagement and governance, coordinates resolution of manufacturing issues, and helps ensure that agreed technical actions are implemented effectively.

Working Conditions

Fully Remote Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova The expected base pay range for this position is $80k– $129k. Please note that base pay offered may vary depending on factors including job‑related knowledge, skills, and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.

Disclaimer

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com. At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together.

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.