Process Development Engineer

Orchestra BioMed; Fort Lauderdale (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

PTO & sick time

Job summary

Orchestra BioMed is seeking an experienced Process Development Engineer to translate manual manufacturing into automation-ready processes and to scale up production. You will work on process characterization, critical parameter identification, and technology transfer with internal teams and external partners.

The role requires hands-on work on automated equipment, DOE studies, and strong documentation in a regulated development environment, with a focus on scalable, validated manufacturing

Qualifications

• Bachelor’s degree in a related engineering or scientific discipline.
• 3–5 years of experience in regulated pharmaceutical, biotech, or medical device manufacturing.
• Hands-on experience with manufacturing, development, or characterization batches.
• Experience defining or optimizing manufacturing process parameters.
• Familiarity with DOE concepts and automated process equipment.

Responsibilities

• Plan and execute process characterization studies on automated process equipment.
• Perform hands-on characterization batches and designed experiments.
• Develop study matrices with senior staff and SMEs.
• Own data collection, organization, and analysis of characterization results.
• Define process setpoints, durations, tolerances, and end‑point criteria.
• Author executable batch records for automated manufacturing equipment.
• Support commissioning, IQ/OQ, and technology transfer activities.

Skills

DOE concepts

Process characterization

Automation awareness

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in Mechanical/Process/Biomedical Engineering

3–5 years in regulated pharma/biotech/medical device

Tools

PLC/SCADA controls

HMIs

Manufacturing historians

Job description

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market- leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications which both represent multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. The Company has a right of first refusal agreement with Terumo Corporation and Terumo Medical Corporation, a leading global medical device company, for a potential transaction related to Virtue SAB for the treatment of coronary artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

Job Summary

We are seeking an experienced Process Development Engineer to support the development, characterization, and scale-up of an automated manufacturing process within the Make and Skid Program. This is a hands‑on, on‑site engineering role responsible for translating existing manual manufacturing processes into well‑defined, automation‑ready process requirements and executing process characterization activities on production‑scale equipment. The engineer will work closely with internal engineering teams, process subject‑matter experts, and external manufacturing partners to establish robust process understanding and support future process validation and technology transfer. This individual will play a central role in ensuring that the process and equipment are technically ready for formal process validation and downstream manufacturing execution. The ideal candidate has 3–5 years of experience in regulated pharmaceutical or medical device manufacturing, direct experience executing manufacturing or development batches, and familiarity with design‑of‑experiments concepts and automated process equipment.

Role and Responsibilities – Including but not limited to:

Process Development and Characterization

• Plan and execute process characterization studies on automated process equipment.
• Perform hands‑on characterization batches and designed experiments, including operation of interim manual equipment where required.
• Develop study matrices in collaboration with senior technical staff and process subject‑matter experts.
• Own characterization data collection, organization, and analysis.
• Support identification of critical process parameters, critical quality attribute relationships, and proven acceptable operating ranges.
• Translate characterization results into process control strategies and Quality-by-Design documentation.

Batch Records and Process Definition

• Convert detailed manual manufacturing batch records into parameterized, automation‑ready process definitions.
• Define process setpoints, durations, tolerances, sequencing requirements, and end‑point criteria.
• Identify undefined or insufficiently specified process parameters and coordinate resolution with internal and external process experts.
• Author executable batch records for automated manufacturing equipment.
• Maintain process definitions as source manufacturing records evolve.

Automation and Engineering Support

• Serve as the primary on‑site process subject‑matter expert supporting operation of the automated skid.
• Translate process requirements into clear engineering inputs for equipment and automation teams.
• Provide process input to user requirements, functional specifications, process flow diagrams, and qualification acceptance criteria.
• Work collaboratively with engineers responsible for PLC/SCADA controls, equipment design, and system integration.
• Support development and refinement of automation‑oriented process flow diagrams.

Qualification and Technology Transfer

• Support commissioning and qualification activities for process equipment.
• Contribute to IQ/OQ execution, including loop checks, I/O verification, calibration verification, and deviation resolution as appropriate.
• Participate in equipment‑focused pre‑validation or mock‑PV runs.
• Compile characterized process parameters, operating ranges, and supporting technical information for technology transfer.
• Support preparation of operating procedures, runbooks, and training materials for manufacturing partners.

Documentation and Compliance

• Generate clear, controlled technical documentation appropriate for a regulated development environment.
• Provide process content supporting DHF documentation, including requirements and design specifications.
• Support requirements traceability and change‑control activities as process knowledge evolves.
• Ensure development and characterization activities are documented in a manner suitable for downstream validation, technology transfer, and regulatory support.

Qualifications – Knowledge & Skills:

• Bachelor’s degree in Mechanical Engineering, Process Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering or scientific discipline.
• 3–5 years of experience in regulated pharmaceutical, biotechnology, or medical device manufacturing.
• Demonstrated hands‑on experience executing manufacturing, development, engineering, or characterization batches.
• Experience defining or optimizing manufacturing process parameters.
• Working knowledge of process characterization and Design-of-Experiments principles; experience executing DOE studies is sufficient.
• Ability to analyze process data and translate results into practical operating ranges and process controls.
• Experience producing clear technical documentation in a controlled or regulated environment.
• Strong cross‑functional communication skills and ability to work with engineering, quality, process development, and external manufacturing teams.
• Ability and willingness to work hands‑on with manufacturing and process equipment in an on‑site environment.
• Experience operating PLC‑controlled or automated process equipment preferred.
• Experience with skid‑based pharmaceutical or medical‑device manufacturing systems preferred.
• Familiarity with process automation, PLC/SCADA systems, HMIs, or manufacturing historians Preferred.
• Experience developing or revising automated batch records Preferred.
• Exposure to equipment commissioning, IQ/OQ, process validation, or technology transfer.
• Familiarity with Quality by Design concepts, including CPP-to-CQA relationships and process control strategy development preferred.
• Experience working with contract manufacturing organizations or external manufacturing partners strongly preferred.
• Familiarity with regulated documentation practices, requirements traceability, GAMP 5, 21 CFR Part 11, or data integrity principles preferred.

A current US work authorization is required in order to be employed by Orchestra BioMed

Why Join Orchestra BioMed

In addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.

EQUAL OPPORTUNITY EMPLOYER

Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Important notice to employment businesses/agencies

Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.