Principle Process Engineer

Catalyze Consulting Group; Boulder (CO); Híbrido; USD 150 000 - 195 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health care

401(k) with a company match

Paid time off

Resumo da oferta

Catalyze Consulting Group is seeking a Principal Process Engineer to lead and manage process engineering projects for pharmaceutical, API and biologics clients in Boulder, CO. With 10+ years of experience, you will drive process design, scale-up, technology transfer and capital project execution while upholding GMP and regulatory standards.

You will coordinate with clients and cross-functional teams, mentor engineers, and oversee front-end studies through CQV documentation, ensuring safe,

Qualificações

• BS in Chemical/Biochemical Engineering or related field.
• 10+ years of process engineering experience in pharma/manufacturing.
• Experience in process design, scale-up, technology transfer and capital projects.
• GMP compliance knowledge and regulatory awareness.

Responsabilidades

• Lead process engineering projects for pharmaceutical, API and biologics.
• Coordinate with client and cross-functional teams.
• Drive process improvements to reduce costs and cycle times.
• Lead technology transfers and CAPEX projects.
• Mentor engineers and ensure CQV documentation.

Conhecimentos

Process engineering

Leadership

Technology transfer

CAPEX management

GMP compliance

Formação académica

BS in Chemical/Biochemical Eng

Descrição da oferta de emprego

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

This position is responsible for leading and managing process engineering projects for pharmaceutical, API and biologics clients. With 10+ years of experience, you will have a strong background in process design, scale-up, technology transfer, capital project execution, and industry-specific regulations. This role requires exceptional leadership, communication and problem-solving skills and will require coordination with the client and cross-functional teams, developing and ensuring adherence to 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

Job Functions, Essential Duties & Responsibilities

• Establishes and maintains strong, transparent and effective day-to-day working relationships with all supported departments, regulatory groups and Catalyze clients.
• Acts as an Owner's representative and trusted technical advisor to Client leadership on process engineering for pharmaceutical, API and biologics facilities.
• Leads interdisciplinary teams that identify, evaluate, and implement 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.
• Leads process troubleshooting teams to resolve operating or product problems.
• Develops and implements innovative process scale-up technologies.
• Leads technology transfers for Client manufacturing organizations.
• Leads interdisciplinary teams responsible for implementation of new technology.
• As part of CAPEX Projects, leads process design from conceptual through detailed design, construction support, commissioning and qualification, supporting implementation into the manufacturing facility.
• Participates in the budget and estimating process for large scale technology transfers and capital projects.
• Assists Clients with interactions to outside interests including trends, available technologies, and process methodologies utilized by industry.
• Leads front-end engineering, feasibility studies, proposals and scope definition, and supports Client presentations and business development for Catalyze.
• 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, and where applicable implements initiatives to continuously improve internal Catalyze process engineering training.
• Leads investigation, recording, reporting and recommended corrective actions for incidents, as needed and as applicable to process engineering related topics.
• 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 (10) years of process engineering experience in a pharmaceutical manufacturing environment, with direct experience in both API and 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.
• Well established history of leading process design, technology transfer and capital project execution in a GMP setting, and liaising with project teams.
• Demonstrated knowledge of complex process equipment and plant scale unit operations.
• Ability to analyze and recommend strategies for improving Client processes while understanding the business objectives (internally and for Catalyze Clients).
• Capability to analyze complex interrelated process systems and facilities.
• Demonstrated leadership, ethical, negotiating and technical skills.
• Professional Engineer (PE) license preferred but not mandatory.

Skill Sets, Core Competencies

• Results oriented approach to performance
• Leadership and negotiation skills
• Ability to build relationships and influence and motivate others
• Ability to achieve results through the positive direction of others
• Ability to provide leadership in all process engineering aspects of manufacturing processes
• Ability to provide leadership in an interactive, interdisciplinary team environment
• Coaching and mentoring skills
• Advanced written and oral communication skills and presentation skills
• Proactive approach to problem identification and resolution
• Analytical problem-solving skills, including the use of LEAN operational excellence systems where applicable
• Ability to understand and apply statistical design of experiments and draw sound conclusions from the results
• Broad technical expertise in chemical and biochemical engineering and process improvement methodology, and demonstrated expertise in pharmaceutical, API and biologics unit operations
• Thorough working knowledge of regulatory compliance issues in regulated manufacturing, including cGMP, PSM, OSHA and EPA requirements
• Ability to influence, manage and direct capital and/or expense projects
• Planning, implementation and follow-up skills
• Adaptable to managing change

Base salary range: $150,000 - $195,000 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.