Commissioning and Qualifications/Computer Systems Valdidation

Lancesoft; Wilson (NC); On-site; USD 90,000 - 125,000; Full time

Job summary

Lancesoft is seeking a Commissioning and Qualifications/CSV professional for an onsite role in Wilson, NC. You will review and approve IQ, OQ, PQ protocols and reports, and ensure regulatory compliance across GMP and FDA standards.

You will coordinate with QA, engineering and manufacturing to implement validated systems and documentation. The ideal candidate holds a Bachelor's in a scientific or engineering field and 2–4 years' validation experience in biotherapeutics/pharma, with strong

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required.
• 2–4 years of biotherapeutic/pharmaceutical validation experience.
• Strong understanding of cGMP, FDA, EMA, ICH guidelines.

Responsibilities

• Review and approve commissioning/qualification documentation (URS, IQ, OQ, PQ).
• Provide QA oversight for C&Q/CSV activities to ensure GMP compliance.
• Support development and implementation of C&Q/validation plans and timelines.
• Perform QA reviews of system impact assessments and equipment categorization.
• Collaborate with engineering, validation, and manufacturing to address quality issues.

Skills

Validation experience

Fast-paced environment

Validation equipment experience

Education

Bachelor's degree in science or engineering

Tools

GAMP 5

ISPE Baseline Guides

Job description

Job Title: Commissioning and Qualifications/Computer Systems Validation

Location: Wilson NC 27893

Duration: 10/26/2026 to 04/28/2028

Role will be ONSITE 100% in Wilson, NC - Neat would be a huge plus - MUST HAVE VALIDATION EXPERIENCE, IT IS REQUIRED

Top 3 Skills: Experience with Validation - Be comfortable with working in fast paced environment - Must have experience performing and approving validation equipment

Essential Job Duties and Responsibilities

Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans. Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project. Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP s, Work Instructions and any other technical document. Review and approves validation protocols and reports (analytical, cleaning, process, etc.) Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements. Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables. Perform QA reviews of system impact assessments and categorization of equipment and utilities. Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies. Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities. Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities. Reviews/approves Technology Transfer documents assuring they meet regulatory and Client requirements. Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.

Additional Job Duties and Responsibilities

Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the Client Standards. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS). Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site. Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues. Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required.

Minimum Qualification

Bachelor's degree in a scientific or engineering discipline is required. Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators as well as Process Equipment Bioreactors, UF/DF, centrifuge, Chromatography systems. Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation. Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles. Strong understanding of risk-based approaches to commissioning and qualification/validation. Proficiency in technical writing for validation and quality documents. Strong communication and interpersonal skills for cross-functional collaboration.

Other requirements

An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements. Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams. Proven ability to manage multiple priorities and work independently with minimal supervision. Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements. Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment. Ability to build and nurture strong and positive relationships. The ability to work in a team environment and interact with all levels of the organization.