The PositionSupport people, equipment and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions for moderate to high complexity issues. Serve as a back-up as needed for the Sr Process Professional and as a mentor/coach for junior team members.
RelationshipsReports to Manager. The role is responsible for collaborating with stakeholders related to assigned area. Support training for lower-level team members.
Essential Functions- Responsible for providing in depth deviation investigations and root cause analysis
- Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications
- Responsible for area content and process knowledge
- Identify and implement process needs and improvement opportunities for moderate to high complexity issues
- Responsible for periodic reviews and reporting. Involved with collaboration across sites
- Update and manage area master data and recipes as needed
- Provide support on defined issues and contributes through application of expertise and knowledge
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case by case basis based on the role.)
Qualifications- Bachelor's degree (engineering, technology or related field of study preferred) from an accredited university required
- May consider an Associate's degree (engineering, technology or related field of study preferred ) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
- May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
- Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
- Excellent written communication skills required
- Thorough investigation and systematic problem-solving experience required
- LEAN manufacturing experience and training required
- General knowledge of change control systems and Quality Management Systems (QMS) required
- Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.)
- Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred
- General experience with regulatory audits/inspections required
- Knowledge of relevant master data preferred
- Validation experience preferred
- Product transfer (or tech transfer) experience a plus
