Senior Process Engineer

Catalyze Consulting Group; Boulder (CO); Hybrid; USD 130.000 - 155.000; Vollzeit

Benefits dieser Stelle

Bonus

Health care

401(k) with company match

Paid time off

Zusammenfassung

Catalyze Consulting Group in Boulder, CO is seeking a Senior Process Engineer with 7+ years of experience to lead process design, scale-up, and technology transfer for pharmaceutical, API, and biologics projects. You will collaborate with clients and cross-functional teams to deliver compliant, efficient capital projects.

The role requires strong technical, communication, and problem-solving skills, with responsibilities including process troubleshooting, CAPEX leadership, and developing

Qualifikationen

• BS in Chemical Engineering, Biochemical Engineering, or related discipline.
• Demonstrated success executing process design and capital project work in GMP settings.
• Experience with API and biologics processes is required or strongly preferred.

Aufgaben

• Establishes and maintains strong relationships with clients and cross-functional project teams.
• Identifies and implements process improvements to reduce costs, improve yields or cycle times, and ensure product quality.
• Analyzes processes and implements robust solutions.
• Performs process troubleshooting to support client manufacturing and development teams.
• Plans and leads process changeovers.
• Develops and implements scale-up technologies for pharmaceutical, API and biologics processes.
• Leads technology transfers and CAPEX project management.
• Prepares equipment specifications and reviews, including PHA reviews.
• Assists with process documentation and CQV deliverables.
• Coaches and mentors junior engineers.

Kenntnisse

Process engineering

GMP experience

Scale-up

Technology transfer

Project management

Communication skills

Problem solving

Leadership

Mentoring

Ausbildung

Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related

Professional Engineer (PE) license preferred

Jobbeschreibung

Catalyze Consulting Group Senior Process Engineer Boulder, CO·Full time

This position is responsible for delivering process engineering on pharmaceutical, API and biologics capital projects for Catalyze clients. With 7+ years of experience, you will have a strong background in process design, scale-up, technology transfer, GMP project execution, and industry-specific regulations. This role requires strong technical, communication and problem-solving skills and will require coordination with the client and cross-functional teams, applying good engineering principles, and facilitating effective communication among stakeholders to ensure successful project outcomes.

About Catalyze Consulting Group

At Catalyze Consulting Group, we are passionate about helping our clients move the world forward. Whether it's advancing groundbreaking therapeutics or establishing innovative industry sectors, we are driven by the desire to make a meaningful impact. Our project teams bring together diverse expertise and solution-focused critical thinking to creatively address challenges and remove barriers to success.

Description

• Establishes and maintains strong, transparent and effective day-to-day working relationships with Catalyze clients, supported departments and cross-functional project teams.
• Identifies, evaluates, and implements process improvements that reduce costs, improve yields or cycle times, improve product quality, resolve or prevent environmental, health and safety impacts, reduce downtime, and improve process consistency.
• Analyzes processes and implements solutions that result in a more robust process.
• Performs process troubleshooting to resolve operating or product problems, supporting Client manufacturing and process development teams.
• Plans and leads process changeovers.
• Seeks and implements innovative process scale-up technologies for pharmaceutical, API and biologics processes.
• Develops and implements detailed plans for large projects, including successful technology transfers, providing leadership and technical project management for such assignments.
• As part of CAPEX Projects, develops process design deliverables and supports implementation into the manufacturing facility, including commissioning, qualification and startup.
• Provides new equipment specifications and reviews, to include Process Hazard Analysis (PHA) reviews.
• Assists Clients with establishing and maintaining process documentation, including process descriptions, operating procedures, technology transfer packages, and CQV documentation.
• Coaches, mentors and trains less experienced engineers and other Client personnel on technical and business issues.
• Supports proposals, scope definition and estimates as requested by Catalyze leadership, and delivers assigned scopes within the hours and budget agreed with the Client.
• Produces work product in compliance with all Client policies and procedures.
• Observe safe working practices including completion of required safety training, attendance at scheduled safety meetings, and performance of safe operating techniques in the labs, production areas, construction sites, and office areas.
• Comply with all Quality, Environmental and Occupational Health and Safety policies and procedures and governmental regulations.
• All other tasks as assigned.

Qualifications, Educations and/or Experience

• At least (7) years of process engineering experience in a pharmaceutical manufacturing environment, with hands-on experience in API and/or biologics processes. Minimum of a BS in Chemical Engineering, Biochemical Engineering, or a related discipline.
• To perform this successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Demonstrated success executing process design and capital project work in a GMP setting.
• Demonstrated knowledge of plant scale unit operations, scale-up, and plant design considerations.
• Ability to analyze processes and recommend solutions that improve robustness while understanding the business objectives of Catalyze Clients.
• Demonstrated technical, project management, and communication skills.
• Professional Engineer (PE) license preferred but not mandatory.

Skill Sets, Core Competencies

• Demonstrated technical expertise in chemical and biochemical engineering and process improvement
• Thorough knowledge of plant scale unit operations, scale-up, and plant design considerations for pharmaceutical, API and biologics manufacturing
• Technical creativity and innovation
• Planning, implementation and follow-up skills
• Working knowledge of regulatory compliance issues in pharmaceutical manufacturing, including cGMP, PSM, OSHA and EPA requirements
• Leadership and skills in negotiation and influencing others
• Training and facilitation skills
• Coaching and mentoring skills
• Problem analysis and troubleshooting skills
• Written and verbal communication skills, including communication with Clients
• Ability to perform complex data analysis
• Results oriented approach to performance

Base salary range: $130,000 - $155,000 per year. Placement within the range depends on experience and qualifications.

Other compensation: Eligible for a bonus.

Benefits: Health care, 401(k) with a company match, and paid time off.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Work is split between office or home-office design work and time at Client sites, including GMP manufacturing areas, laboratories, and active construction sites. Travel to Client sites is required as project needs dictate. The employee is frequently required to sit, stand, walk, and work at a computer for extended periods, and is occasionally required to climb stairs, ladders, or platforms, wear PPE or cleanroom gowning, and lift up to 25 pounds.