Senior Specialist, Equipment Commissioning & Qualification

Celgene-posted 3 months ago
$86,490 - $104,803/Yr
Full-time • Mid Level
Hybrid • Warren, NJ
Merchant Wholesalers, Nondurable Goods
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The Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Process Equipment projects and ongoing work activities of low to moderate complexity, individually and with support of others. The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures.

  • Author, review, approve, and execute equipment qualification protocols, plans, summary reports, protocol deviations, and other validation deliverables as required.
  • Author, review, and approve equipment risk assessments, system categorization assessments, and change control impact assessments.
  • Propose, present, and execute change controls for equipment introduction, modification, and retirement.
  • Provide input and feedback for change strategy, qualification approach, compliance gaps, and risk mitigation.
  • Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests within the computerized maintenance management system.
  • Procure new CQV equipment and implement associated procedures to support process equipment qualifications.
  • Train new users to operate CQV equipment and troubleshoot as needed.
  • Create, revise, and periodically review procedural documents for CQV equipment such as temperature and humidity mapping systems, CO2 instruments, and LN2 foggers.
  • Coordinate system usage to maintain CQV timelines while adhering to system calibration and maintenance schedules.
  • Perform data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment.
  • Lead and support workflows related to quality events and actions including deviations, investigations, proactive initiatives, and corrective and preventive actions.
  • Create, revise and periodically review CQV program SOPs and associated work instructions/practices.
  • Administer and perform system periodic reviews and CQV document periodic reviews, and review/approve corresponding deliverables.
  • Periodically update the CQV validated systems list.
  • Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations.
  • Serve as a subject matter expert for equipment qualification in internal and regulatory audits.
  • BS in an Engineering/Science discipline required or minimum of 6 years of experience leading equipment qualifications.
  • Minimum of 6 years of experience in FDA-regulated industry.
  • Minimum of 4 years of experience developing and executing equipment qualifications, process validations, and/or test method validations.
  • Strong background and experience in laboratory and manufacturing operations, with advanced knowledge of cGMP pharmaceutical manufacturing and associated process equipment utilized for cell therapy clinical manufacturing.
  • Experience executing temperature/humidity mapping qualifications for controlled storage areas and/or controlled temperature units (incubators, refrigerators, freezers, cryogenic storage systems) is required.
  • Highly preferred experience designing and performing airflow visualization studies for biological safety cabinets, isolators, and controlled/classified areas.
  • Preferred experience commissioning and qualifying isolators and filling/capping equipment, with a technical background and basic understanding of operation and changeover of aseptic fill/finish technology.
  • Process oriented with strong problem solving and critical thinking skills.
  • Excellent technical writing skills and proficiency with Microsoft Word formatting functions.
  • Detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program.
  • Strong multi‐tasking ability in conjunction with proven organizational skills.
  • Excellent communication and interpersonal skills; communicate effectively, efficiently, and in a timely manner.
  • Experience dealing with a diverse workforce; team oriented and professionally mature.
  • Highly proficient in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.
  • Strong understanding of quality management systems, document management systems, records management, and data integrity principles.
  • Experience interacting with external and/or internal auditors in a compliance audit environment, with direct interaction including face to face interaction in response to audit questions is preferred.
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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