Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support

Job Title: Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support

Duration: 12 Month Contract (Possible extension based on work performance)

Location: Warren, NJ 07059

Onsite Position

Work Schedule: Mon - Fri, Business Hours

ABOUT ROLE:

Must haves:

a. BA/BS degree required, BS or more advanced degree in science/engineering preferred

b. Minimum 4 years of equipment qualification execution and technical writing experience in FDA – regulated industry (pharmaceutical/medical device/biotechnology)

1. PURPOSE AND SCOPE OF POSITION:

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.

2. REQUIRED COMPETENCIES:

Knowledge, Skills & Abilities:

• 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.

3. DUTIES AND 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 BMS 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.

4) EDUCATION AND EXPERIENCE

a. BA/BS degree required, BS or more advanced degree in science/engineering preferred

b. Minimum 4 years of equipment qualification execution and technical writing experience in FDA – regulated industry (pharmaceutical/medical device/biotechnology)