Position Summary:
Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, specification and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors.
Changes to individual responsibilities may occur due to business needs and other related duties may be assigned.
Position Responsibilities:
- Represent the Instrument Operations Validation group as the validation subject matter expert in manufacturing operations value streams and project teams, ensuring validation requirements and deliverables are communicated to the teams.
- Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.
- In collaboration with end users, process owners, quality engineers and other team members, develop validation protocols and oversee execution of IQ, OQ, PQ for manufacturing processes and systems.
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. Coordinate with end users and process owners to resolve identified issues to bring validation to acceptable levels.
- Write report summarizing results and statistics for all the validation projects.
- Support Change Request and Change Notification (CR/CN) activities and provide Validation Impact Assessment.
- Be accountable for timely completion of all validation deliverables in accordance with manufacturing needs and project timelines.
- Review existing validation reports and identifies gaps for compliance. Develop strategies and plan to close the gaps in an efficient and technical manner.
- Participate as an active member for new product development teams.
- Participate in project management meetings as Validation representatives determining validation requirements, as needed.
- Learn and understand the applicable technology and engage in technical discussions.
- Identify areas and opportunities to improve manufacturing facilities, processes, and equipment.
- Collaborate and provide consultation to other departments performing validation activities.
- Ensure validation program meets requirement of FDA (21 CFR Part 11) and ISO 13845.
- Provide guidance and supervision to Junior Staff.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
- Strong organization skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.
- Candidate must be able to effectively lead teams, interface well with the manufacturing and service organization, and has a proven track record of transferring products to manufacturing.
- Related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech) is preferred.
- Knowledge and working application of FDA and cGMP requirements.
- Knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management.
- Knowledge and working application of reding and understanding of technical drawings.
- Knowledge and working application of Standard Operation Procedures.
- Demonstrated ability to accomplish goals while working cross functional and globally.
- Excellent interpersonal, written, and verbal communication skills.
- Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically.
- Demonstrated strong analytical problem solving.
- ValGenesis eVLMS and Teamcenter PLM experience is a plus.
- Proficiency in MS Office.
- Experience with Statistics, SPC and DOE is a plus.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
- Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
