What are the responsibilities and job description for the Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support position at Eclaro?
Commissioning/Qualification Specialist/Specific Commissioning and Validation Support
Job Number: 24-03074
Job Number: 24-03074
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Commissioning/Qualification Specialist/Specific Commissioning and Validation Support for our client in Warren, NJ.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers.
- The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification.
- With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
- As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Required Skills:
- Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
- Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures
- Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
- Familiarity with 21 CFR Part 11 compliance.
- Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
- Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
- Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems
- Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas
- Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
- Ability to interact effectively with cross-functional groups.
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
- Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals and drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
- Strong computer skills in Microsoft Office Suite – Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
Responsibilities:
- Manage projects of limited scope and complexity.
- Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
- Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.
- Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
- Create all documents in compliance with Client standards and policies.
- Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
Qualifications:
- BA/BS degree required, BS or more advanced degree in science/engineering preferred
- Minimum 4 years of equipment qualification execution and technical writing experience in FDA – regulated industry (pharmaceutical/medical device/biotechnology)
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
Sofia Dela Torre
Sofia.DelaTorre@eclaro.com
(332) 206-0779
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
