Senior Engineer, Commercial Technical Operations

Keenova Therapeutics plc; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 80,000 - 129,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova Therapeutics plc is hiring a Senior Engineer, Commercial Technical Operations to oversee sterile drug product manufacturing at external CMOs. This hybrid role in the Philadelphia area includes travel to sites, focusing on aseptic filling, lyophilization, CCIT, and process validation.

You will lead investigations, CAPA, risk assessments, and continuous improvement with cross-functional teams. Required: 7+ years in sterile product manufacturing, Bachelor’s in a related field, and strong

Qualifications

• 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 environment.
• Demonstrated experience supporting aseptic filling operations for vials and/or prefilled syringes; experience with both presentations preferred.
• Working knowledge of cleanroom operations, aseptic technique, contamination control, environmental monitoring interfaces, and EU GMP Annex 1.
• Working knowledge of 21 CFR 210/211, USP guidance, and EU GMP Annex 1; knowledge of 21 CFR Part 4 & 820 an advantage.
• Experience with lyophilization, terminal sterilization, CCIT, or self-injectable device assembly; external CMOs and tech transfer experience preferred.
• Lean and/or Six Sigma problem-solving methods with Green Belt or higher certification preferred.

Responsibilities

• 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 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, and lifecycle improvement.
• Lead or support technical investigations, deviation and CAPA development, root-cause analysis, change control, and corrective actions.
• Develop and improve contamination control strategies with cross-functional teams (Quality, Manufacturing, Microbiology, Engineering, and CMOs).
• Provide technical support for container closure systems and CCIT, including assessment of changes and integrity issues.
• Support technology transfer, process validation, continued process verification, process capability assessment, and manufacturing improvements for sterile products.
• Support combination products and self-injectable device packaging, assembly, and related investigations and changes.
• Prepare, review, or approve technical assessments, protocols, reports, risk assessments, SOPs, batch record changes, and governance materials.
• Apply Lean and Six Sigma to improve robustness, compliance, throughput, and cost effectiveness.
• Build relationships with external partners and internal stakeholders and escalate risks impacting quality or supply.
• Maintain current knowledge of regulatory expectations for sterile manufacturing and translate into practical controls.

Skills

Aseptic filling

Lyophilization

CCIT

Cleanroom operations

Lean Six Sigma

Risk assessment

Communication

Education

Bachelor’s degree in pharmaceutical sciences or engineering

Advanced degree preferred

Job description

**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 escalate 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 OperationsThis 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.