Talent.com
Process Engineer
Process EngineerSerán BioScience • Bend, OR, US
[error_messages.no_longer_accepting]
Process Engineer

Process Engineer

Serán BioScience • Bend, OR, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description

Job Description

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  https : / / www.seranbio.com / careers  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

    We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

    [job_alerts.create_a_job]

    Process Engineer • Bend, OR, US

    [internal_linking.similar_jobs]
    Facility in OR Needs a Locums Rheumatologist

    Facility in OR Needs a Locums Rheumatologist

    Weatherby Healthcare • Bend, US
    [job_card.full_time]
    Weatherby can help you build a custom career plan, with multiple positions available for you today.Call us for specific details on your future job today. Mon-Fri schedule excluding holidays with lik...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Fleet and Facility Maintenance Director - Career Growth Opportunities

    Fleet and Facility Maintenance Director - Career Growth Opportunities

    Sysco • Redmond, OR, United States
    [job_card.full_time]
    This is an Operations position responsible for directing the activities associated with the general maintenance, repair, and appearance of the facility, fleet shop, outside grounds, office space, b...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physical Therapist Salaried

    Physical Therapist Salaried

    ProActive Physical Therapy Specialists • Bend, OR, USA
    [job_card.full_time]
    Build Your Nest Egg - All Full-Time PTs Receive Stock Options, Because You Make A Difference!.Physical Therapists - $30,000 in. ProActive Physical Therapy Specialists.What We Offer Our Full-Time Phy...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Postal Mail Processor - Hiring Nationwide

    Postal Mail Processor - Hiring Nationwide

    Postal Jobs Source • Bend, OR, US
    [job_card.full_time] +1
    NO EXPERIENCE REQUIRED – PAID TRAINING PROVIDED – JOB SECURITY.The Postal Service is the largest government related agency in terms of employees. The Postal Service currently employs nea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Data Entry Product Support - No Experience

    Data Entry Product Support - No Experience

    GLOCPA • Redmond, Oregon
    [job_card.full_time]
    We’re looking for Customer Support Product Testers across the US to work from home and help top brands improve their products before they hit the market.[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physical Therapist

    Physical Therapist

    Upstream Rehabilitation • Redmond, OR, United States
    [job_card.full_time]
    Step & Spine Physical Therapy, a brand partner of Upstream Rehabilitation, is looking for a Physical Therapist to join our Outpatient Clinic in Redmond, OR. We are committed to your personal and pro...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physical Therapist

    Physical Therapist

    Step & Spine Physical Therapy • Redmond, OR, United States
    [job_card.full_time]
    Physical Therapist at Step & Spine Physical Therapy summary : .Step & Spine Physical Therapy is seeking a dedicated Physical Therapist for their outpatient clinic in Redmond, OR.The role emphasizes o...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Postal Mail Processor - Paid on the Job Training

    Postal Mail Processor - Paid on the Job Training

    Postal Jobs Source • Bend, OR, US
    [job_card.full_time] +1
    NO EXPERIENCE REQUIRED – PAID TRAINING PROVIDED – JOB SECURITY.The Postal Service is the largest government related agency in terms of employees. The Postal Service currently employs nea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Fleet and Facility Maintenance Director - Hiring Immediately

    Fleet and Facility Maintenance Director - Hiring Immediately

    Sysco • Bend, OR, United States
    [job_card.full_time]
    JOB SUMMARY This is an Operations position responsible for directing the activities associated with the general maintenance, repair, and appearance of the facility, fleet shop, outside grounds, off...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Postal Mail Processor - Paid on the Job Training

    Postal Mail Processor - Paid on the Job Training

    The Postal Service • Bend, OR, US
    [job_card.full_time] +1
    NO EXPERIENCE REQUIRED – PAID TRAINING PROVIDED – JOB SECURITY.The Postal Service is the largest government related agency in terms of employees. The Postal Service currently employs nea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Postal Mail Processor - Hiring Nationwide

    Postal Mail Processor - Hiring Nationwide

    The Postal Service • Bend, OR, US
    [job_card.full_time] +1
    NO EXPERIENCE REQUIRED – PAID TRAINING PROVIDED – JOB SECURITY.The Postal Service is the largest government related agency in terms of employees. The Postal Service currently employs nea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Process Engineer

    Process Engineer

    Serán BioScience • Bend, Oregon, United States, 97701
    [job_card.full_time]
    Sern 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 operatio...[show_more]
    [last_updated.last_updated_variable_days]
    Fleet and Facility Maintenance Director

    Fleet and Facility Maintenance Director

    Sysco • Redmond, OR, United States
    [job_card.full_time]
    JOB SUMMARY This is an Operations position responsible for directing the activities associated with the general maintenance, repair, and appearance of the facility, fleet shop, outside grounds, off...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote FP&A Manager – AI Trainer ($50-$60 / hour)

    Remote FP&A Manager – AI Trainer ($50-$60 / hour)

    Data Annotation • Bend, Oregon
    [filters.remote]
    [job_card.full_time] +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Postal Mail Processor - Hiring Nationwide

    Postal Mail Processor - Hiring Nationwide

    Postal Source • Bend, OR, US
    [job_card.full_time] +1
    NO EXPERIENCE REQUIRED – PAID TRAINING PROVIDED – JOB SECURITY.The Postal Service is the largest government related agency in terms of employees. The Postal Service currently employs nea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Investment Analyst – AI Trainer ($50-$60 / hour)

    Remote Investment Analyst – AI Trainer ($50-$60 / hour)

    Data Annotation • Redmond, Oregon
    [filters.remote]
    [job_card.full_time] +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Drive with DoorDash - Start Earning Quickly

    Drive with DoorDash - Start Earning Quickly

    DoorDash • Bend, OR, United States
    [job_card.full_time] +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Gastroenterologist Opportunity in Bend, Oregon

    Gastroenterologist Opportunity in Bend, Oregon

    CS St. Charles Health System • Bend, OR, US
    [job_card.permanent]
    Pacific Northwests most desirable locations.Comprehensive GI practice with outpatient, ASC, and hospital-based settings.Advanced endoscopy opportunities (EUS / ERCP) welcomed but not required.Support...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]