Senior Commissioning and Qualification Specialist

DPS Group

$90K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Preferred team leadership experience in validation projects with 2-5 team members.
  • Familiarity with automation systems such as BSCs and Centrifuges is advantageous.
  • Minimum of 3 years of experience in temperature mapping is preferred.
  • Must provide legal work authorization for the US; relocation may be considered.

Responsibilities

  • Manage procurement and implementation of new equipment assets.
  • Develop and update user standard operating procedures (SOPs).
  • Troubleshoot technical issues with current assets.
  • Conduct user training for new system users.
  • Review audit trails and user access for compliance.
  • Oversee calibration schedules and equipment usage management.
  • Author and approve qualification deliverables as needed.

Benefits

  • Comprehensive medical, dental, and vision coverage.
  • Employee assistance programs (EAP) offered.
  • 401K with company contributions.
  • Generous paid parental leave.
  • Accrual of 15 days of paid time off (PTO) annually plus nine paid holidays.
  • Opportunity for tuition reimbursement and adoption assistance.
Full Job Description
About The Job
Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.
We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together.

Role description:
Arcadis is seeking a Senior Specialist, Equipment Commissioning & Qualification that will be a technical subject matter expert for qualifying new class B2 systems and a compliance lead for ensuring existing class B2 systems remain in a qualified state.

Role accountabilities:

Procure and implement new assets

Create, revise, periodically review equipment user SOPs

Troubleshoot existing assets

Train new users

Perform audit trail review and user access reviews

Coordinate system usage and calibration schedules

Author, review, and approve CQV deliverables (execute as needed)

Create, revise and periodically review CQV program SOPs, FMEAs, and risk assessments

Administer and perform system periodic reviews and associated CQV document periodic reviews and review/approve corresponding deliverables

Periodically revise the ECQ validated systems list to update information pertaining to the qualified state of all class B2 systems.

POC development change management SME leads and supports the implementation of change controls related to new and existing class B2 systems

POC quality management system SME leads and supports workflows related to quality events and actions including deviations, CAPAs, and proactive initiatives

POC system lifecycle SME reviews/approves calibration plans, preventative maintenance schedules, system criticality/risk/classification assessments, alarm assessments, and asset induction/change requests within the computerized maintenance management system

Other duties as assigned

Qualifications & Experience:

Experience leading a team of 2-5 in validation projects is preferred.

Experience with the following list of systems is preferred: BSCs, CTUs, Centrifuges, Clinimacs, Welders, Sealers, Cryotanks, Cryocarts, etc...

3+ years of temperature mapping experience is preferred.

Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Why Arcadis?
We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It's why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.
You'll do meaningful work, and no matter what role, you'll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.
Together, we can create a lasting legacy.
Join Arcadis. Create a Legacy.
Our Commitment to Equality, Diversity, Inclusion & Belonging
We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.
Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.

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