Senior CQV Support Validation Consultant (x6) - Bothell, WA (REF9154O)

Job Description

Our client is looking multiple Senior Commissioning and Qualification Validation Consultants for a 12-month,on-site project based at their Bothell, Washington facility.This position supports the REF FM Validation team within the Real Estate & Facilities. This position is responsible for performing Gap Analysis, CAPA, and Change Control. This position also supports IQ/OQ and/or PQ activities, re-qualification, enrollment or commissioning for utilities and equipment used in GMP work environment. This person is responsible for creating, updating, and maintaining assignment associated documentations and reports. Duties and responsibilities to include, but are not limited to:

• Responsible for leading a project and oversight of validation deliverables among multiple groups in the organization.
• Ensures clear communication and alignment between cross-functional groups.
• Authors, executes and/or reviews validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations.
• Schedules and executes validations per standard operating procedures and regulatory guidelines.
• Lead assigned validation related investigations
• Champion and lead continuous improvement efforts on every aspect of validation
• Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
• Foster cross-departmental relationships (QC, Materials Management, Manufacturing, QA, and site leadership) by representing Validation at team meetings.
• Employ good document practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.
• Use Good Engineering practice on assigned duties.
• Champion assigned CRs and/or CAPA in coordinating with multiple stakeholders
• Work independently with minimal managerial oversight.
• Apply strategies and prioritize with management
• Revising and maintaining assigned validation procedures

Qualifications

• Must have a minimum of 3-5 years directly relevant cGMP Validation work experience in utilities and/or equipment in biotech, pharmaceutical or health care industry required.
• Must have working knowledge of cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, Data Integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), industry good practices for Installation Qualification/Operational Qualification/Performance Qualification and Standard Operating Procedures.
• Must have a prior experience handling documentations related to Change Control and CAPA
• Strong technical background in the area of Facilities/Utilities and Engineering is a plus.
• Strong technical writing skill is a plus.
• Good written and oral communication skills.

Additional Information

Allcandidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.