Equipment Engineer

1 day ago

Woodstock, United States Woodstock Sterile Solutions Full time
Job DescriptionJob Description

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package.


I. Position Overview:

The position is responsible for specifying, procuring, and implementing new equipment in the WSS facility. This position will have a strong focus on packaging equipment. The incumbent will identify long term and short term goals in regards to reducing costs in the packaging areas for all aseptic blow, fill, seal and packaging lines at the WSS facility.

II. Specific Duties, Activities, and Responsibilities:

  • Test and install new equipment for manufacturing.
  • Support equipment through validation, start-up, and continuous process improvement.
  • Create drawings of all equipment tooling as well as package materials used in manufacturing.
  • Write and facilitate approval of user requirements, change control documents, design specifications, and acceptance test documents for equipment based projects.
  • Develop and maintain project plans, manage equipment related projects from inception through project close out.
  • Compile equipment specifications from existing recent equipment projects and develop additional specifications where needed to develop a current specification library for typical equipment projects at the site. Maintain the specification library as specifications are updated for new projects and from lessons learned, etc.
  • Prepare requests for quotation based on User Requirements specifications for multiple bidders for equipment projects. Review bids and recommend vendor(s) for selection for equipment projects.
  • Define, describe, evaluate, and effectively communicate equipment requirements to both technical experts and non-technical audiences.
  • Act as key resource in troubleshooting technical machine based issues in manufacturing.
  • Providing engineering support to our 24x7 operations requires periodic phone and / or in-person support after work hours and weekends.
  • Develop strategic plans to improve manufacturing efficiency and reduce costs by providing automation solutions.
  • Up to 10% travel required to perform Factory Acceptance Testing and/or identify appropriate equipment.
  • Maintain effectiveness of the Quality System components relevant to this position.
  • Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
  • Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

  • Bachelor of Science in Mechanical Engineering, Electrical Engineering or equivalent experience.

Experience:

  • Minimum 5 years Equipment Engineering experience required, 8-10 years experience preferred.
  • Knowledge of change control and validation is desired.
  • Experience with packaging equipment in the pharmaceutical, food, or cosmetic industry a plus. (Packaging equipment includes: pouching equipment, cartoners, labeling equipment, scanners, and vision systems.)
  • Experience working in a cGMP controlled environment.
  • Six Sigma / Lean Manufacturing / Professional Project Management skills a plus.

Knowledge/Skills Requirements:

  • Demonstrated intermediate mathematical aptitude.
  • High level of attention to detail.
  • Excellent documentation skills.
  • Strong Mechanical aptitude.
  • Strong communication skills both written and oral.
  • A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.
  • Strong problem solving and analytical skills.
  • Must possess appropriate communication skills allowing direct interaction with outside suppliers, WSS internal Managers and Sr. Management.
  • Ability to work independently on multiple projects.
  • Works well in a team environment.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Must be able to perform risk assessments in a timely manner and act accordingly.
  • Should be familiar with cGMP or be able to quickly learn and apply cGMP principals and must be able to follow safe work practices.
  • Demonstrate a willingness to share skills and information with others.
  • Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically.
  • Demonstrate a bias toward action. Get things done. Be willing to take a position, and assert influence to drive improvement. Foster teamwork to get results.
  • Demonstrated ability to read, write, and speak clear English.

Physical Requirements:

  • Ability to stand for up to 10 hours per day.
  • May be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others
  • Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, stooping, kneeling, crouching, talking, bending, grasping, listening.
  • Occasional, walking up inclines and uneven terrain, writing, balancing, carrying
  • Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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