SHIFT

A BRIEF OVERVIEW
The Engineer II, Validations guides the process of validations for special processes and manufacturing processes for Orchid Alabama to ensure that Orchid's manufacturing processes are efficient, safe, and best-in-class. He/she reports to the Operations Manager and works with Manufacturing Engineers and the leadership team at the site.

WHAT YOU WILL DO

• Creates, requests, and/or updates various documentation including customer-specific requirements

• Participates in and occasionally leads problem solving teams utilizing lean manufacturing methods.

• Receives training and development in various phases of engineering work.

• Maintains a safe and healthy work environment by following company standards and procedures.

• Participates in the required training that is delivered to the site team in support of site goals, objectives, and program management milestones.

• Supports definition of One Orchid processes as defined by the Director, Operations Excellence Transformation. Implements best practices as these practices are defined.

• Provides support to team members to ensure that they have the required knowledge and skills prior to performing job duties.

• Mentors shop employees on improvements to manufacturing methods, products and new production equipment.

• Assists in creating Standard Work Instructions for various operations and occasionally collaborates with Quality Control Inspectors.

• Interacts and communicates with customers to inform them of critical details on new product launches.

• Performs and assists in validations and revalidations as necessary.

• Advocates for the health and safety of self, co-workers, customers, and the community.

• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

• Completes all required training.

• Maintain the Validation Master Plan (VMP)

• Lead the development of validations and implementation

• Create IQ, OQ, PQ for validations.

• Create IQ, OQ, PQ reports for validation activities

• Provide executive summary reports for special process validations

• Perform weekly, monthly, quarterly, and yearly testing as needed to support on-going monitoring of validation activities.

• Participate in the development of process and facilities planning, capital expenditure, and cost savings programs

• Develop and deliver training to maintenance engineers and manufacturing operators on new or modified systems

• Plan, schedule and coordinate equipment installations

• Prepare and present project status reports and tracking to goals

EDUCATION QUALIFICATIONS

• Bachelor Engineering or related field (Required)

EXPERIENCE QUALIFICATIONS

• 3+ Years of Engineering Experience (Required)

• 5+ Years of Engineering Experience (Preferred)

• Experience with Orchid's Manufacturing Process (Preferred)

• Manufacturing Experience (Preferred)

• Specialization in Validations (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Operational Functions - Basic Knowledge

• Quality Management - Working Experience

• Problem Solving - Working Experience

• Communication - Basic Knowledge

• Accuracy and Attention to Detail - Working Experience

• Manufacturing Trends & Directions - Working Experience

• Lean Manufacturing - Working Experience

• Drafting - Basic Knowledge

• Tool and Die Design - Working Experience

• Manufacturing Equipment - Working Experience

• Robotics/Computer Controlled Machinery - Basic Knowledge

• Change Leadership - Basic Knowledge

• Collaboration - Working Experience

• Customer Support - Working Experience

• Computer-aided Design (CAD) - Working Experience

• Consulting - Working Experience

• Training - Working Experience

PHYSICAL DEMANDS

• Must be able to remain in a stationary position - Occasionally

• Must be able to move about the inside of the building - Frequently

• Must be able to move equipment around the building - Rarely

• Must be able to ascend/descend stairs or ladders - Rarely

• Must be able to position oneself and move under/around/over equipment - Occasionally

• Must be able to handle/adjust/inspect/position various items and equipment - Occasionally

• Must be able to communicate and exchange information with others - Constantly

• Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment - Occasionally

• Must be able to distinguish and detect information such as writing and defects - Constantly

WORKING CONDITIONS

• Noise - Occasionally

WHAT WE OFFER

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values:
  • Integrity First: We do the right thing
  • Teamwork: We are one Orchid
  • Results: Our results matter

ADDITIONAL REQUIREMENTS

• Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
• Candidates must be able to provide proof of eligibility to work in the United States through eVerify

EOE, including disability/vets