Process Engineer II

Antech; Longmont (CO); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Tuition reimbursement

Life Insurance

Disability Insurance

Pet Care Discounts

Parental Leave

Job summary

Antech is seeking a Process Engineer II to maintain day-to-day manufacturing operations, improve equipment and ensure product quality and yield. You will work with cross-functional teams under the manager and contribute to transferring and developing new products and processes.

We value disciplined documentation, adherence to GMP/regulatory practices, and continuous improvement methods to support growth and operational excellence across our manufacturing footprint.

Qualifications

• Bachelor’s degree in engineering; master’s degree preferred.
• Five to seven years in an R&D or production environment with process improvement experience.
• Experience in a regulated environment (FDA, ISO) preferred.
• Experience in project management preferred.
• Experience in medical device field, specifically in invitro diagnostics, preferred.
• Certifications such as ISO, PMP, LEAN, Six Sigma, cGMP preferred.

Responsibilities

• Lead sustaining efforts to support operations using continuous improvement principles and root-cause analysis to implement corrective actions.
• Ensure on-time equipment milestone deliveries to enable company growth.
• Recommend and implement equipment and process modifications to improve production efficiencies and yields for existing products.
• Develop high-level capital equipment integration protocols for manufacturing.
• Conduct DOE and SPC analysis to identify causes of yield loss and improve quality; maintain GR&R, yield tracking, and CpK analyses.
• Document all work products to align with IQ/OQ/PQ requirements and ensure equipment qualifications.

Skills

Communication skills

Problem solving

Data analysis

Team collaboration

Self-motivation

Attention to detail

Education

Bachelor’s degree in engineering

Master’s degree preferred

Experience in regulated environments (FDA/ISO)

Project management experience

Experience in medical device field

Certifications: ISO, PMP, LEAN, Six Sigma, cGMP

Tools

SolidWorks

Windows

MS Office

Job description

We understand that the world we want tomorrow starts with how we do business today, and that’s why we’re inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other’s growth and development. Our culture is centered on our guiding philosophy, The Five Principles: Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of MarsScience & Diagnostics, a family-owned company focused on veterinary care.

Current Associates will need to apply through the internal career site. Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.

The Target Pay Range for this position is $84,000 - $105,000 annually. At Antech, pay decisions are determined using factors such as relevant job-related skills, experience, education, training and budget.

Job Purpose/Overview

A Process Engineer II is required to maintain day-to-day operations in manufacturing, maintaining and improving upon existing equipment as well as ensuring product quality and yield. A Process Engineer II works closely with other teams and under the guidance of their manager to transfer and develop new products and processes. A Process Engineer II understands appropriate documentation in a regulated environment, implementing corrective actions, and experience with continuous improvement principles.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to satisfactorily perform each essential function. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead efforts to provide sustaining support to operations utilizing continuous improvement principles and technical support to operations utilizing root cause analysis to implement corrective actions.
• Enables company growth by ensuring on-time equipment milestone deliveries.
• Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products.
• Assists in developing high level capital equipment integration protocols and procedures for manufacturing.
• Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality. Active database and data management allowing for process performance assessment via GR&R, Yield Tracking and Cpk analysis.
• Accurately documents all work products to ensure equipment qualifications and in line with and follow IQ, OQ, PQ requirements.
• Interacts with design staff to ensure that processes and designs are compatible with existing equipment.
• Translate design requirements into production by defining, designing and/or communicating efficient and capable process tooling.
• Utilizing GDP, author documents including but not limited to manufacturing Standard Operating Procedures (SOPs), and detailed work instructions.
• Trains manufacturing staff on proper processes to follow when operating equipment, including wave-guide instrument(s).
• Ensures that team and staff members follow safety rules and protocol.
• Other duties as assigned.

Education and Experience

• Bachelor’s degree in engineering or related field required; master’s degree preferred.
• Five to seven (5-7) years prior experience in an R&D or production environment with proven success of process improvement and scale-up projects.
• Experience in a regulated environment (FDA, ISO, etc.), preferred.
• Experience in project management preferred.
• Experience in the medical device field, specifically invitro diagnostics, preferred.
• Licenses or certifications such as ISO, PMP, LEAN, IFMA, MPS, Six Sigma, cGMP, preferred.

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills; able to communicate technical information to technical and non-technical staff to ensure understanding.
• Excellent problem-solving skills and demonstrated ability to collaborate in problem solving.
• Excellent data gathering and analysis skills.
• Excellent electro-mechanical equipment development and troubleshooting skills.
• Knowledge of QMS, including experience with deviation, CAPA, and other quality related objectives and requirements.
• Software use and knowledge: Windows, MS Office products, SolidWorks (or similar).
• Able to develop effective partnerships across the organization and to serve as a liaison between R&D and Manufacturing.
• Self-starter, with ability to work on own initiative.
• Highly organized and able to balance multiple demands and priorities.

Travel

Will there be notable travel in this position? Yes

Percent of time: 10%

Working Conditions

Complete how the job gets done and the way it operates

The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding. The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms. The associate is frequently required to hear and speak in order to use the telephone, make presentations and communicate with people in an office environment. The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 25 pounds.

Work will be performed in an office, laboratory, and assembly/manufacturing environment. Able to use standard office equipment, know and understand laboratory safety protocols, and operate in an around process assembly equipment. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, database management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams.

About Antech

Antech is a leader in veterinary diagnostics, driven by our passion for innovation that delivers better animal health outcomes. Our products and services span 90+ reference laboratories around the globe; in-house diagnostic laboratory instruments and consumables, including rapid assay diagnostic products and digital cytology services; local and cloud-based data services; practice information management software and related software and support; veterinary imaging and technology; veterinary professional education and training; and board-certified specialist support services.

Benefits

Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.

Benefits eligiblity is based on employment status.

• Paid Time Off & Holidays
• Medical, Dental, Vision (Multiple Plans Available)
• Basic Life (Company Paid) & Supplemental Life
• Short and Long Term Disability (Company Paid)
• Flexible Spending Accounts/Health Savings Accounts
• Paid Parental Leave
• 401(k) with company match
• Tuition/Continuing Education Reimbursement
• Life Assistance Program
• Pet Care Discounts

Commitment to Equal Employer Opportunities

We are proud to be an Equal Opportunity Employer - Veterans / Disabled. For a complete EEO statement, please see our Career page at Antech Careers.

Note to Search Firms/Agencies

Antech Diagnostics, Inc. and its subsidiaries and affiliates (Antech) do not compensate search firms for unsolicited assistance unless they have a written search agreement with Antech and the requisition is position-specific. Any resumes, curriculum vitae, and other unsolicited assistance from search firms that do not have a written search agreement or position-specific requisition submitted to any Associate of Antech will be deemed the sole property of Antech and no fee will be paid in the event the candidate is hired by Antech.