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3 дня назад

Associate Specialist - Equipment Design and Facilities Engineering (Onsite)

71 900 - 113 200$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Specialist - Equipment Design and Facilities Engineering (Onsite) (GMP facilities and equipment): Maintaining and improving laboratory facilities and equipment for drug substance development and GMP clinical manufacturing with an accent on reliability, compliance, and safe equipment operations. Focus on executing maintenance strategies, supporting capital projects, troubleshooting equipment, and implementing root cause analysis across potent, multi-modality development facilities.

Location: Onsite in Rahway, New Jersey, United States. Travel requirements: 10%.

Salary: $71,900–$113,200 per year, plus eligibility for annual bonus and long-term incentive where applicable.

Company

hirify.global develops and manufactures pharmaceutical products, including drug substance development and GMP clinical manufacturing programs.

What you will do

  • Maintain laboratory and utility equipment by developing and executing maintenance strategies.
  • Provide technical oversight of internal and third-party maintenance teams and coordinate corrective, preventive, and annual shutdown maintenance.
  • Support asset compliance, equipment qualification, audit readiness, and GMP work in collaboration with Quality groups.
  • Support equipment and process troubleshooting and develop safe, compliant setups with visibility to pilot plants.
  • Execute equipment reliability initiatives, facility improvement projects, capital and expense projects, and new technology implementations typically ranging from $10K to less than $1MM.
  • Support incident root cause analysis, documentation, reporting, and action-item management.

Requirements

  • BS in Engineering and at least 1 year of experience in facility maintenance and/or project management.
  • Strong mechanical aptitude and demonstrable knowledge of facilities and equipment from an operations and maintenance perspective.
  • Familiarity with process flow diagrams and/or mechanical drawings.
  • Effective communication and collaboration skills, including the ability to work with process teams, Quality groups, maintenance teams, and contractors.
  • Ability to gather data, evaluate options, make recommendations, and contribute to or lead problem-solving efforts.
  • Fluency in Microsoft Office, email, and meeting facilitation.
  • Ability to apply cGMP and safety requirements in a compliance-focused environment.

Nice to have

  • Knowledge of change management processes and principles.
  • Experience working with skilled trades, including piping, electrical, millwrights, instrumentation, contractors, and vendors.
  • Maintenance experience in GMP environments and familiarity with US and EU safety and GMP regulations.
  • Experience operating or maintaining laboratory-scale equipment and reading P&IDs.
  • Experience with potent compound processing, containment systems such as isolators, or cleanroom facilities.
  • Experience with Hexagon EAM for plant maintenance and SAP for financial business systems.
  • Experience with Process Analytical Technology and electrical classifications for solvents and dust, including Class I and II, Divisions I and II.
  • Experience working under SOP and/or cGMP documentation and with high-risk work such as Lockout/Tagout, Hazardous Energy Control, elevated work, and confined space entry.

Culture & Benefits

  • Regular employee status with onsite work; flexible work arrangements are not applicable.
  • Medical, dental, vision, and other insurance benefits for employees and families.
  • Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
  • Hazardous materials are present in the laboratory work environment.

Hiring process

  • Visa sponsorship is not available.
  • A valid driving license is not required.
  • The posting is available to residents of the United States, Canada, and Puerto Rico through this careers site.

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