Process Engineer
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Serán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems, and operational readiness for our new commercial manufacturing operations. This position will ensure that all systems, equipment, and workflows are designed, installed, and commissioned to meet cGMP standards and support efficient, compliant production. Beyond the initial launch phase, this individual will be instrumental in sustaining manufacturing operations by driving long-term operational excellence. This includes leading continuous improvement (CI) projects to ensure that all systems, equipment, and workflows remain efficient, compliant with cGMP standards, and capable of meeting evolving production demands.
Duties and Responsibilities
Facility & Process System Start-Up
- Lead design and engineering activities associated with process equipment for new installations and/or continuous improvements
- Lead engineering activities for facility process systems through design, installation, and commissioning, including CIP, purified water, solvent distribution, and compressed gases
- Oversee process equipment installation, commissioning, and qualification (URS, FAT, SAT, IQ/OQ/PQ)
- Coordinate with vendors and contractors to ensure timely and compliant start-up of manufacturing systems
- Develop and execute commissioning plans, risk assessments, and readiness checklists
Process Design & Optimization
- Design and refine commercial-scale manufacturing processes for oral solid dosage forms and enabling technologies
- Perform capacity analysis, cycle time studies, and throughput modeling to ensure production efficiency
- Implement Lean and Six Sigma methodologies to reduce waste and improve process reliability
- Conduct formal risk assessments for existing process system to proactively mitigate quality and safety risks
Operational Readiness
- Drive readiness activities for commercial launch, including supporting process validation and GMP documentation
- Partner with Validation, QA, and Manufacturing to ensure compliance with regulatory requirements
- Support tech transfer from development to commercial scale
- Collaborate with the Facilities and Maintenance teams to establish preventive and predictive maintenance schedules for process systems
- Draft and review standard operating procedures (SOPs) for the operation, cleaning, and troubleshooting of new process systems
Continuous Improvement
- Analyze production data to identify bottlenecks and implement corrective actions
- Drive cost reduction initiatives and efficiency improvements without compromising quality
- Participate in deviation investigations and CAPA implementation
- Serve as the primary technical process system owner to ensure stable and robust manufacturing
Project Management
- Contribute to project timelines, resource planning, and budget adherence
- Facilitate cross-functional project meetings and provide regular status updates to senior leadership
- Provide engineering input during client audits and regulatory inspections
- Proactively identify project risks and implement mitigation strategies
Skills, Abilities and Education Requirements
Required
- BS/MS in Industrial Engineering, Chemical Engineering, Mechanical Engineering, or related discipline
- 8+ years of experience in pharmaceutical manufacturing, process engineering, or industrial engineering
- Hands-on experience with facility start-up, commissioning, and equipment qualification
- Strong knowledge of cGMP requirements and commercial manufacturing operations
- Proficiency in process modeling, workflow analysis, and Lean/Six Sigma tools
- Excellent communication and documentation skills
Preferred
- Experience with oral solid dosage forms and enabling technologies (e.g., spray drying, blending, granulation, tableting, encapsulation, & tablet coating)
- Familiarity with facility design for regulated environments
- Knowledge of ERP/MES systems and digital manufacturing tools
- Project engineering experience in a regulated industry
Core Competencies
- Analytical problem-solving and data-driven decision-making
- Ability to work cross-functionally in a fast-paced environment
- Strong organizational skills and attention to detail
- Continuous improvement mindset
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer
- Prolonged periods of sitting, standing, and moving throughout a manufacturing environment
- Must be able to lift fifteen pounds at times
- Adheres to consistent and predictable in-person attendance
Compensation correlates to skills and experience presented by selected candidate. Visit to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
Skills
As published by lever · 21 questions
Basics
Resume/CV, Full name, Email, Phone, Current location, Current company
Short answers (5)
- If someone from Serán initiated contact and referred you to this role, please type their name below optional
- If yes, please explain: optional
- Please indicate your desired compensation: optional
- What is your date of availability for employment? optional
- Are you subject to any restrictions related to potential employment with Serán? Restrictions include noncompetition, nonsolicitation, no hire, or confidentiality. If yes, please provide an explanation (include name of company and description of restriction without disclosing any confidential or proprietary information to Serán)
Pick from a list (15)
- Have you ever worked for Serán BioScience before?
- Do you have experience in the pharmaceutical industry?
- Without providing dates of enrollment, can you confirm that you have completed the necessary education requirements of the position? optional
- Are you able to perform the essential functions of this job without reasonable accommodations? Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for qualified applicants/employees to perform essential job functions.
- As of this date, can you present evidence of your identity and legal right to work in this country?
- Would you need VISA sponsorship now or in the future?
- Can you travel if the position requires it?
- Can you relocate if the position requires it?
- Have you ever been terminated from or asked to resign from a job? optional
- I certify that all statements made in connection with this application (whether contained herein (and/or any supplements) or made by me or others at my request during the course of the employment process) are true and complete in al respects. I acknowledge and agree that any incorrect, incomplete, false, fraudulent, or misleading statements made by me, either verbally or in writing, and/or any omission, concealment, or failure or answer any question fully, completely, and accurately, whether made by me or others at my request, will result in rejection of this application, denial of employment, or termination from employment if discovered after employment.
- I authorize the investigation of all matters which Serán deems relevant to my qualifications for employment, including, without limitation, work records, reference checks, education, and an investigation into my driving record. I authorize and request that all my present and former employers, references, educational institutions, and any others to furnish and release information about me, my employment record, and/or education, including a statement of reason for the termination of my employment and information regarding my work performance, disciplinary reports or actions, abilities, degrees obtained, transcripts, licenses and certifications, and other qualities and information Serán deems pertinent to my qualifications for employment. I release Serán (and all providers of information) from all claims and/or liabilities arising out of or in any way connected with Serán's background investigation. If employed, I release Serán from any claims and/or liabilites for future references it may provide regarding my work history and performance with Serán.
- I understand that if offered employment, I will be required to submit proof of my identity and legal right to work in the United States as a condition of employment.
- I understand that any job offer may be contingent on me successfully passing a criminal background check/investigation. I release Serán from all claims and/or liabilities resulting from or related to the criminal background check/investigation.
- I understand that any job offer may be contingent on me successfully passing a pre-employment drug screen. I agree to hold harmless and release Serán and its agents from all claims and/or liabilities resulting in whole or part out of the collection of specimens, testing and the appropriate use of the information from such testing.
- I understand that, if employed, my employment relationship with Serán will be at-will. Therefore, subject to applicable law, my employment may be terminated (and I may voluntarily resign) at any time, for any reason or no reason, with or without cause or prior notice. Nothing contained in this application, or provided in connection herewith, will be construed as an offer or promise of employment, nor does this application create any employment contract or guarantee that employment or any benefit will be provided or continued for any period of time.
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