Technical Investigator
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Job Location:
Walker, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
At West were a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily Wests indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future
Theres no better place to join an inclusive community of professionals with opportunities for lifelong learning growth and development. Supported by benefit programs we empower the physical mental emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
This is a fully onsite role candidates must live within 50 miles of the Grand Rapids/Walker location.
Job Summary
Reporting to the Value Stream Lead within Operations the Senior Associate Technical Investigator serves as a sitelevel technical leader for complex problem solving systemic nonconformance reduction and continuous improvement. This role drives highquality investigations ensures compliance with the Quality Management System and champions proactive datadriven improvements across operations. The Senior Associate partners with crossfunctional leaders to strengthen process capability prevent recurrence and enhance product and process robustness in a regulated medical device environment.
Essential Duties and Responsibilities
- Leading and facilitating complex multi departmental investigations to ensure accurate root cause identification and the development of robust sustainable corrective and preventive actions that eliminate recurrence and strengthen quality systems.
- Serving as technical subject matter resource on investigation methodology elevating the consistency and efficiency of the sites problem solving processes.
- Ensuring all investigations meet or exceed internal Quality standards regulatory requirements and industry best practices.
- Driving advanced date gathering trending statistical analysis and performance monitoring to identify systemic issues process variability and opportunities for proactive improvements before defects occur.
- Deploying Lean Six Sigma and advanced problem solving tools and coaching others in their effective use to build problem solving capability throughout the organization.
- Acting as owner for investigation of related processes recommending and implementing improvements in templates workflows documentation standards and training content.
- Ensuring timely complete and well supported documentation of investigations CAPAs and associated risk assessments in alignment with compliance requirements and business needs.
- Supporting and guiding peer investigators providing mentorship and technical feedback to enhance investigation quality.
- Representing investigations during internal and external audits providing clear and confident justification of root cause corrective actions and verification of effectiveness.
- Collaborating closely with Engineering Quality Operations and Supply Chain to drive rapid closure of day to day quality issues effective troubleshooting and alignment on long term solutions.
- Proactively identifying improvement opportunities related to process robustness documentation quality equipment performance operator error proofing and automation.
- Acting in accordance with company Guiding Principles Code of Conduct and all EHS requirements.
Education
- Must have aBachelors degree in Engineering Quality Science or related discipline.
Work Experience
- Must have 8 years work experience in the Medical Pharmaceutical or high-volume regulated manufacturing environment with at least 5 years directly involved in investigations quality engineering or process engineering roles.
Preferred Knowledge Skills and Abilities
- Advanced understanding of injection molding processes (standard and multicomponent) molding equipment tooling automation systems and key process parameters.
- Demonstrated excellence in technical writing with the ability to produce clear persuasive and auditready documentation.
- Proficiency with advanced rootcause tools (8D A3 Ishikawa 5 Why FMEA) and ability to coach others in their application.
- Solid understanding of statistics data analytics SPC control charts and statistical software packages.
- Strong communication skills with the ability to influence crossfunctional stakeholders and facilitate effective technical discussions at all levels.
- High proficiency in computer and digital systems including integrated manufacturing systems data visualization tools and standard business software.
- Ability to manage multiple complex tasks simultaneously work independently and make sound timely judgments.
- Strong interpersonal skills with proven ability to work across departments and influence without authority.
Travel Requirements
- Must be able to travel up to 5% of the time or when required.
Physical and Mental Requirements
- Ability to work in a fastpaced manufacturing environment while maintaining accuracy and composure.
- Strong organizational skills attention to detail and selfmotivation.
- Ability to collaborate cross-functionally in a matrixed environment and manage competing priorities.
- Ability to maintain confidentiality resolve conflicts and handle sensitive issues with professionalism.
- Demonstrated ability to make independent datadriven decisions.
Shift
M-F Days
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe treated fairly valued and respected. We do not discriminate on the basis of race religion color national origin gender sex gender identity sexual orientation age marital status veteran status disability status or other applicable legally protected characteristics. Where permitted by law employment with West Pharmaceutical Services Inc. or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of post-offer background screening.
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Key Skills
- Epidemiology
- Public Health
- Bank Secrecy Act
- Bioinformatics
- Fraud
- Genetics
- Interviewing
- Law Enforcement
- Qualitative Research Interviewing
- Research Experience
- Next Generation Sequencing
- Writing Skills
About Company
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products.
