BFS Mechanic

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position will be scheduled to work Thursday - Saturday and every other Wednesday, 6:00AM - 6:00PM.

I. Position Overview:

The position is responsible for maintaining manufacturing equipment to allow for efficient and safe production of quality product.

II. Specific Duties, Activities, and Responsibilities:

• Install, perform, and document scheduled preventative maintenance activities on Blow/Fill/Seal Machines and ancillary production support equipment.
• Write and perform preventive maintenance (PM) procedures of production machinery.
• Troubleshoot and repair production equipment as necessary to maintain required production capacity.
• Monitor and maintain the production infrastructure in an acceptable state of operation.
• Comply with all company controlled documentation, cGMPs, and site specific policies, and internal approved procedures as they pertain to equipment and maintenance.
• Document the execution of maintenance activities, as required, on appropriate documentation (i.e. maintenance work orders, log books and forms) in a timely and efficient manner.
• Adhere to all safety requirements specified in controlled documentation and in equipment manuals.
• Support projects and miscellaneous activities as deemed by management.
• Maintain equipment at a high level by performing quality work.
• Maintain manufacturing equipment to allow for efficient and safe production of quality product.
• Provides consultation concerning packaging problems and improvements in the packaging process.
• Sets up and reviews machinery for production in accordance with approved Batch Records.
• Performs preventive maintenance procedures over various department equipment.
• Assists in the training of preventive maintenance procedures.
• Assists in the selection, installation, validation, and preventive maintenance of packaging equipment and components.
• Devises, fabricates, and assembles new or modified mechanical components or assemblies for industrial equipment and machinery, power equipment, servo systems.
• Understands and applies the use of tools, machine tools, and measuring instruments.
• Sets up and conducts tests of complete units and components under operational conditions to investigate design proposals for improving equipment performance or other factors, or to obtain data for development, standardization, and quality control.
• Work with manager to administer Maintenance software
• Provide written suggested updates to SOP’s to department leader
• Maintain utility area to the highest level of cleanliness
• Assist in repair of production equipment when needed (i.e., filling equipment, storage tanks)
• Professionally interacts with other departments when needed
• Understands and assist in implementing safety procedures and cGMP’s
• Available for 24 hr. call in when requested
• Repairs tooling and machinery including the creation of tooling, fabrication and repair of parts as needed.
• Reviews Standard Operating Procedures (SOP’s) for new equipment.
• Researches machinery design and development adapting or modifying production equipment accordingly.
• Responsible for all aspects of equipment set-up of the production equipment assigned to the business unit.
• Responsible for compiling area specific shift information and line status data in an accurate and timely fashion and reporting that information to the support groups as well as the oncoming shift management team.
• Assist in the bench strengthening and in-depth cross-functional training of all members of the team.
• Assist the Technical group with Projects and process improvements
• Be a liaison between the parts crib team and the production team to ensure the correct equipment is supplied for operations and returned in a timely manner.
• Assist in the training of line technicians on the process equipment.
• Responsible for placing Maintenance Work Orders and ordering operating supplies and consumables when necessary.
• Work with LSS Black Belts on projects for business unit improvements.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

• High School Diploma or equivalent
• Associates Degree or Technical certificate preferred

Experience:

• Minimum 5 years industry specific maintenance experience required.
• Experience in a pharmaceutical manufacturing cGMP environment desired.

Knowledge/Skills Requirements:

• Demonstrated intermediate mathematical ability.
• High level of attention to detail.
• Strong Mechanical aptitude.
• Strong communication skills both written and oral.
• Strong problem solving and analytical skills.
• Ability to work independently on multiple projects.
• Works well in a team environment.
• Works well under pressure and able to prioritize workloads.
• Must be able to interact effectively with a variety of individuals and styles within and between departments.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Must be able to perform risk assessments in a timely manner and act accordingly. Successful candidate will possess strong computer and troubleshooting skills as well as solid reading, writing, math and communication skills.
• Should be familiar with cGMP and safe work practices.
• Be knowledgeable. Bring experience to the organization. Learn new skills; collect new information. Demonstrate a willingness to share skills and information with others.
• Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically.
• Demonstrate a bias toward action. Get things done. Be willing to take a position and assert influence to drive improvement. Foster teamwork to get results.
• Demonstrated ability to read, write, and speak clear English.

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.