Job Description

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Biopharma Equipment Validation Specialist

Location: Portsmouth, NH (Onsite)

Duration: 12 months

Pay rate: $70 - $83 hr. on W2 AI

Notes:

Area: Manufacturing, QC, Validation

Level: Advanced - 5-10 years

Job Summary:

Equipment Validation Specialist role ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The role provide Operations, Quality Assurance and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment.

Description : Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.

Drive/own the validation plans and execution of equipment changes and process improvements.

Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.

• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
• Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.
• Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
• Perform assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA)

Perform other duties as assigned

Quality

Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.

Safety

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety, the safety of their team and the safety of others.

Skills

• Advanced technical knowledge of Quality control and manufacturing operations.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors
• Strong written and verbal communication skills
• Ability to work in MS Project, Word, Excel, PowerPoint

Education:

Degree (required): Bachelor of Science, Field of Study, Science related discipline or relevant experience in the field

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

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