Production Equipment Technician

Production Equipment Technician

ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.

ALK has an opening for a full-time Production Equipment Technician, located in our Oklahoma City, OK facility.

Area of Responsibilities

The following is a list of specific duties, which are essential functions of this job. This list is not all-inclusive, and the employee who occupies this position is expected to assume any/all duties assigned by management, irrespective of whether such duties are specifically included in this list.

• Responsible for operating and facilitating production equipment activities in support of the automated high-volume sterile fill production line.
• Ability to learn and be trained in all production technician roles.
• Maintain a positive work atmosphere by behaving and communicating in a manner that gets along with co-workers and supervisors.
• Ensure company goals of safety, quality and production are met while maintaining a clean and orderly work environment.
• Capable of working independently and within a group environment.
• Maintain workflow by monitoring steps of the process; setting processing variables; observing control points and equipment.
• Facilitating corrections to malfunctions with process control points.
• Provide support to all manufacturing areas to assure cGMP compliance, evaluation, and improvement of current processes through direct interactions/dialogue with production mgmt.
• Maintain a safe and clean work environment by training personnel on the use of all control points, equipment, and resources while stressing good housekeeping.
• Maintaining compliance with established policies and procedures to improve safety and material flow.
• Implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
• Assist, as a Subject Matter Expert (SME), to conduct manufacturing related investigations such as unexpected events, deviations, and product related customer complaints.
• Maintain qualification for and is able to perform sterile gowning which is applicable for the manufacturing area of responsibility.
• Initiate continuous process improvements by observing and analyzing production performance, records, and data.
• Assist, as an SME, to conduct change controls to improve processes and procedures.
• Write and revise manufacturing and operation SOPs and Batch Records.
• Conduct training sessions with manufacturing operators.
• Make recommendations to Senior Management for areas of improvement.
• Special assignments and misc. projects from Manufacturing Manager and Senior Management.
• Must be punctual, reliable, and work extra hours if needed prior to or after their normal shift.
• Actively involved in avoiding/minimizing, troubleshooting and resolving production problems by making sure resources, tools and equipment are available.
• Directly interface, as needed, with clients and regulatory authorities during routine and unannounced inspections.
• Performance and completion of these duties will be performed in accordance within the guidelines of the company's SOP's.
• Must assist in the performance of planned preventive and unplanned maintenance assigned by the OKC Facilities/Validation Manager.
• Provide support for the introduction of new equipment or modification of equipment.
• Be knowledgeable performing review, authoring and revisions of Standard Operating Procedures and related manufacturing process documentation.
• Assist in development of projects of Automation, Control and Instrumentation (PLCs, sensors etc)

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Physical/Mental: Up to 90% of time spent on production floor. Continuous mental and/or visual attention to manufacturing functions. Must be a problem solver. Continuous standing throughout up to an 8 hour period. Must be able to effectively communicate through multiple mediums such as voicemail, email, written correspondence, and presentations. Lifting up to 50 lbs., frequent pulling, pushing and bending.
• Business Environment: Effective judgment in a fast-paced, results-orientated environment. Typical environment includes working in office, manufacturing and laboratory areas.

Competences

Competences required to fulfil the area of responsibilities and work assignments:

• Education: High School Diploma or equivalent and a minimum of 2-year experience in aseptic manufacturing and/or maintaining automated equipment.
• Experience: Experience in operating and maintaining automated equipment.
• Prior experience with cGMP activity preferred.
• Willing to be held accountable and must work well with others to ensure that all objectives are met on a regular basis.
• Solid written and verbal communication skills.
• Demonstrated ability to comply with required safety practices.
• Able to work in a team across departments and sites.
• Ability to work independently.
• Must have good attention to detail.
• Basic computer skills with Microsoft Office products are beneficial.
• Good time management skills with daily operations and special projects.
• Basic knowledge and understanding of mechanical systems.
• Must be receptive to sudden and frequent changes in priorities.

ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Job Type: Full-time Pay: $18 - $25 per hour Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance