Validation Specialist – Thermo Fisher Scientific – Allentown, PA, USA
Position Summary: Working independently and with Fisher Clinical Services (FCS) staff, the Validation Specialist is responsible for performing the day-to-day QA management of FCS’ Computer Systems Validation Program. This includes providing QA support for all computer systems application development, testing, validation, change control, impact analysis, regression testing, re-validation and development of all validation lifecycle deliverables required by FCS’ System Development Life Cycle (SDLC) and validation methodology.
Essential Duties and Responsibilities:
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Conducts all activities in a safe and efficient manner.
- Develops and maintains FCS Validation methodology to guide software development, validation and maintenance in accordance with applicable Quality/Regulatory requirements, FDA Guidance Documents on Software Validation and industry best practices.
- Develops and maintains FCS Validation strategies, policies and SOPs implementing a predicate rule, risk-based approach to fully support the attainment and maintenance of a validated state of compliance for all regulated computerized systems used by the organization.
- Provides interpretation and recommends FCS position on compliance with FDA Regulations regarding Validation related issues, i.e., Electronic Records/Electronic Signatures.
- Provides oversight of the validation of software and hardware systems to ensure that validation is correctly and effectively implemented.
- Provides oversight of the creation, collection, execution, approval and archiving of all validation lifecycle documentation related to the validation of FCS software and hardware systems.
- Assists with execution of Validation Master Plan/Validation Plans as required.
- Trains users and IS support personnel in validation methodologies, policies and SOPs.
- Provides supervision to validation specialists/assistants in support of the above functions.
- Partners with other FCS staff functions to provide validation guidance to ensure compliance with FCS validation methodology, policies and SOPs.
- Responsible for development, maintenance and management of quality metrics including recommending and assisting with implementation of improvement initiatives.
- Works with FCS sites to assure consistency in validation strategy/approach for global projects.
- Performs/ conducts special projects assigned by management.
- Other duties may be assigned to meet business needs.
- Basic Minimum Qualifications (BMQ): Proficient in MS Excel and MS Word
- Experience in ERP type systems (SAP, JDE or etc.)
- 3-5 years work experience as a technical writer
Education/ Experience (BMQ): Bachelor’s degree (B.A./B.S.) from a four-year college or university. Minimum five (5) years experience in an FDA- regulated environment. Five (5) years of pharmaceutical Quality Assurance or Validation experience is preferred.
· Certificates and/ or Licenses (BMQ): ASQ Software Quality Engineer preferred Internal and External Contacts: A high degree of interaction with internal and external contacts is required at all levels company-wide. Internally, direct contact may occur with any department or site; frequent interactions are expected with Production/Operations, Engineering, Client Services and Logistics/Distribution. External contact with clients in support of FCS Validation Program, projects and capabilities, FCS Allentown capabilities presentations and plant tours are required.
Ability and/or Skills:
The individual in this position must possess the following skills and/or abilities to be effective in the role:
- Managing, motivating, mentoring, coaching.
- Customer focus.
- Process improvement and performance management.
- Collaboration, teamwork and influencing.
- Prioritization and decision-making.
- Verbal and written communication.
- Effective information presentation and query response.
- Analytical and problem solving.
- Proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook).
- Proficiency in global supply chain management processes including order fulfillment, distribution, customs, and receiving for both ambient and cold chain products.
- Proficiency in supply chain management regulatory requirements for pharmaceuticals and biologicals such as import/export, duties, hazardous materials and cGMPs.
- Work Schedule: 8:00 am – 5:00 pm core hours. Occasionally required on-site at early start times, off-shift hours or weekends, as needed.
- Other Factors: May be required to lift 10 – 20 pounds.
- Some walking in warehouse and production area required.
- Should be self-directed, and be able to work well independently and in a group.
- Position requires good organizational skills as well as good written and oral communication skills.
- Travel is required to visit locations and other FCS sites as necessary; overnight travel approximately 10%.
- May be required to travel domestically and internationally.
- May be required to participate in global project teams.
This position has not been approved for relocation assistance.