Specialist, Manufacturing

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

This position will require working in various Controlled/Non-Classified areas. The Technician performs a variety of manufacturing tasks (operates equipment, performs visual, cosmetic, and physical inspection, line clearances, OEE data

collection and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) in accordance with cGMPs.

Primary Responsibilities

• Perform the duties of using the approved tools to create defect units that will be used in Inspection defect kits.
• Conduct evaluations on other team members for training qualifications.
• Perform cleaning and housekeeping for assigned areas as required to maintain a cGMP environment.
• Perform GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed.
• Knowledge of product security controls and kit reconciliation.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process Manager.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals.
• Obtain knowledge to be able to print off SOP's/Forms via ECMS.
• Review process documents such as operational SOPs, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Assist with creating and maintaining visual inspection standards.
• Assisting with investigations and resolving visual inspection issues.
• Collaborating with cross functional teams to address any challenges.
• Operate defect lab equipment in accordance with EHS and Quality standards.
• Perform all other assigned duties with minimal supervision under the direction of the Manager.
• Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Inspection Team.
• Ability to work effectively in a team environment.
• Candidate should possess the ability to work in and adapt to a changing/demanding environment.
• Some overtime may be required with minimal advance notice to support business needs.

Other Responsibilities

• Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
• Perform all other assigned duties with minimal supervision under the direction of the Manager or designee as needed.

Optional Training / Responsibilities

• Obtain cold room training/access to be able to transfer materials in and out of the cold rooms.
• Take proper training to become certified trainer on assigned process tasks.

Minimum Requirements:

• Prior experience in a pharmaceutical or cGMP regulated environment
• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.
• Ability to work with a variety of hand-held tools and different glass types.
• Must be able to pass an eye exam

Preferred Background:

• High school graduate, vocational school graduate or equivalent
• Prior production experience
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

Work Schedule: 8 hours - Monday- Friday

The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

This position may also include the following conditions:

Does the job require:

Specific visual skills (i.e., extensive reading or computer use, normal color vision, depth perception, or visual acuity)

Specific hearing requirements

If specific requirements, please describe:

Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors; seeing with 20/20 (or better) vision, with or without correction.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $26.00 - $39.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.