Manufacturing Equipment Specialist

2 weeks ago

Windsor, Colorado, United States TOLMAR Full time
Objective and Overview

This role is dedicated to providing engineering expertise to Tolmar's diverse packaging and production facilities. The position focuses on equipment-specific implementations, enhancements, and modifications for both novel and existing machinery that influence the Manufacturing and Equipment Engineering Department. Responsibilities include overseeing, monitoring, and supporting various equipment elements (such as quality, safety, operation, compliance, validation, and testing) for both developmental and commercial purposes within Tolmar.

Key Responsibilities
  • Comprehend design elements and characteristics of primary (tubes, pumps, jars, syringes, vials, etc.), secondary (cartons, semi-rigid trays, etc.), and tertiary (shippers, etc.) packaging component systems.
  • Collaborate with Original Equipment Manufacturers (OEMs) and third-party solution providers to assess options for different equipment systems utilized in manufacturing areas.
  • Draft and evaluate technical User Requirements Specifications (URS), Installation/Operational/Performance Qualifications (IQOQPQ), and Change Controls (CC) necessary for various equipment systems in manufacturing.
  • Create and assess technical work instructions, Standard Operating Procedures (SOPs), preventative maintenance documentation, and recommended spare parts lists for equipment systems in manufacturing.
  • Coordinate with team members to revise manufacturing batch records to mitigate operational impacts from equipment changes or updates.
  • Educate personnel from various departments (Maintenance, Process Development, Packaging Engineers, and Manufacturing) on equipment functionalities.
  • Promote continuous enhancement in quality, efficiency, and safety for both new and existing equipment.
  • Assist, lead, and conduct investigations, address customer complaints, and implement related Corrective And Preventative Actions (CAPA) concerning equipment challenges.
  • Support testing initiatives for equipment line evaluations.
  • Assist and/or lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) and validation processes for new equipment as required.
  • Contribute to the research and selection of new or refurbished equipment, parts for equipment modifications, and system integration alternatives.
  • Provide assistance to other departments for products in the development stage.
  • Engage in special projects and additional responsibilities as assigned.
Knowledge, Skills & Competencies
  • Comprehension of various components involved in equipment design and operation, including mechanical, electrical, pneumatic, and automation aspects.
  • Familiarity with PLC logic, Equipment Integration, and Automation principles.
  • Proven ability to coordinate cross-functional project teams.
  • Experience in a collaborative team environment.
  • Strong written and verbal communication abilities.
  • Capability to manage multiple projects concurrently.
  • Self-motivated with the ability to work effectively both independently and collaboratively.
  • Aptitude for navigating ambiguity and maintaining effectiveness during periods of uncertainty and change.
  • Basic understanding of analyzing, troubleshooting, and identifying issues, along with recommending and implementing cost-effective solutions.
  • Working knowledge of various manufacturing equipment (tube & syringe fillers, sealers, crimpers), bottling lines (fillers, cappers, labelers), tray packaging (Thermoformers, cartoners), and vision inspection systems (track and trace, label inspection) is preferred.
  • Proficiency in various drafting/prototyping software (e.g., AutoCad, Solidworks, Google Sketch-up) is preferred.
  • Participation in mandatory annual hazardous waste training. Involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste during production or sampling processes, and transfer of hazardous waste between lab procedure areas, satellite accumulation, and storage. Respond to spills following Chemical Spill Procedures.
  • Must hold a valid driver's license and maintain an acceptable Motor Vehicle Record (MVR).
Core Values
  • The Equipment Engineer II is expected to align with Tolmar's Core Values:
    • Consistently uphold the highest standards of ethics and compliance.
    • Take responsibility for your actions, successes, and setbacks.
    • Show respect for colleagues and recognize that honest collaboration is essential for company success.
    • Go above and beyond to achieve results.
    • Demonstrate commitment to all endeavors and the patients served.
    • Embrace change with enthusiasm.
    • Strive to understand customer and patient needs, acting swiftly and efficiently regardless of the task.
Education & Experience
  • Bachelor's degree in Engineering or a related field.
  • A minimum of three years of experience working with equipment in a manufacturing setting.
  • Familiarity with requirements in a regulated industry, including pharmaceuticals, healthcare, or medical device manufacturing, is preferred.
Compensation and Benefits
  • Salary: $90,000 - $97,000 annually, based on experience.
  • Benefits offered.
Tolmar's compensation programs emphasize equitable and fair pay practices, including market-based base pay and a comprehensive benefits package. Final compensation may vary based on the selected candidate's qualifications and experience.

Working Conditions
  • Work environments include office, laboratory, and manufacturing settings.
  • Position may necessitate occasional weekend and/or evening work.
  • Must be capable of lifting up to 35 lbs.
  • Travel up to 10% of the time may be required (both international and domestic).
Tolmar is an Equal Opportunity Employer. We do not discriminate based on age, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation, or any other applicable status protected by state or local law. Our intention is to provide equal opportunity to all qualified applicants, with selection decisions based on job-related factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or discriminate against employees or applicants for inquiring about, discussing, or disclosing their own pay or that of another employee or applicant. However, employees with access to compensation information as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals without access to that information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)

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