Manufacturing Technician II - Inspection (PFS 2 Days)

Resilience; Olde West Chester (OH); On-site; USD 28,929 - 44,083; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Healthcare package

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Other paid leaves of absence

Tuition reimbursement

Caregiving support

Job summary

Resilience is a technology-focused biomanufacturing company transforming how medicines are made. The Manufacturing Technician II reports to a Manager/Supervisor in the Inspection Process Execution Team (PET) and works in Controlled/Non-Classified areas performing equipment operation, inspection, and batch record entries.

Responsibilities include operating automated inspection equipment, visual/physical/material inspection, 5S participation, and data collection of OEE.

Qualifications

• Experience in a pharmaceutical or cGMP regulated environment.
• Ability to read, write, and follow instructions in English.
• Good attention to detail is required.
• Capable of keeping accurate records and performing mathematical calculations.

Responsibilities

• Operate automated inspection equipment and monitor status.
• Perform visual, cosmetic, and physical inspection of materials.
• Elevate concerns to Lead/Manager as needed; obtain visual inspection qualification.
• Use material handling equipment and perform line clearance activities.
• Maintain cGMP documentation and logs; support 5S and Kaizen activities.
• Perform cleaning, batch records, and SOP adherence; support OSHA procedures.

Skills

Pharma/cGMP exp

English proficiency

Attention to detail

Record keeping / math

Mechanical aptitude

Tools

SAP inventory

Job description

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

Brief Job Description

The Manufacturing Technician II reports to a Manager/Supervisor in the Inspection Process Execution Team (PET) operations. 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 operating assigned machinery consisting of servicing automated inspection equipment, monitoring equipment status, reintroduction of materials, manually palletizing inspected materials, and assuring a smooth flow of product.
• Perform manual visual, cosmetic, and physical inspection of material.
• Promptly elevate concerns to Lead and Manager/Supervisor as needed.
• Must obtain and maintain visual inspection qualification.
• Be able to start up equipment, make minor adjustments to machinery, remove jams, minor troubleshooting, and minor assembly/disassembly for cleaning purpose.
• Ability to use material handling equipment such as motorized and manual pallet jacks, non-motorized lifts.
• Perform cleaning, housekeeping and line clearance activities for assigned areas as required to maintain a cGMP environment.
• Perform batch record and GMP documentation entries.
• Maintain records and/or logs as required in the performance of job responsibilities, including mathematical computation where needed.
• Knowledge of product security controls and material handling equipment.
• Responsible for outgoing quality level.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls.
• Report all discrepancies to process facilitator.
• 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.

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.
• 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.
• Be flexible and support other work areas as needed.
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator 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 equipment and process tasks. Train and conduct evaluations on other team members for training qualifications. Obtain a novice to intermediate level of knowledge of SAP inventory movements and inventory management such as moving items from one storage location to another and goods issuing items to process orders as required.

Competencies & Job Requirements

Acquire and maintain all required certifications and qualifications for the assigned work area. Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution 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.

Minimum Qualifications

• 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.

Preferred Qualifications

• Prior production experience.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.
• Prior inspection experience in a pharmaceutical manufacturing environment.
• 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.

Benefits

• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Healthcare package including medical, dental and vision.
• Family building benefits.
• Life and disability insurance.
• Paid vacation.
• Paid holidays.
• Other paid leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.

Our target base pay hiring range for this position is $21.50 - $32.00 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.

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.