Facilities Technician/GMP Tech II

LNN Pace Analytical Life Sciences, LLC; Norristown (Montgomery County); On-site; USD 33,000 - 52,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401K retirement plan with employer-mat

Paid time off

Job summary

Pace Analytical Life Sciences is seeking a Facilities Technician/GMP Manufacturing Technician II for a full-time, onsite role in Norristown, PA. Shift options are 6:30 a.m.–3:00 p.m. or 7:30 a.m.–4:00 p.m.

The position involves dispensing, manufacturing, packaging, and general facility tasks in a cGMP environment, with emphasis on SOPs and data integrity. The role requires a High School Diploma or GED (some college preferred) and about one year of manufacturing experience, plus familiarity with

Qualifications

• High School Diploma or GED required; some college or technical training preferred.
• One year of manufacturing operations or technical experience is preferred; or an equivalent combination of education and experience.
• Familiarity with GMP, cGMP, FDA regulations and SOPs is expected.

Responsibilities

• Assist with dispensing, manufacturing, and packaging of GMP materials while wearing PPE.
• Complete manufacturing batch records in accordance with GMP documentation requirements.
• Perform tasks in clean rooms; clean equipment, instrumentation, and manufacturing suites.
• Maintain accurate records to support data integrity and compliance.
• Adhere to SOPs, cGMPs and applicable FDA regulations.
• Accept shipments of raw materials and complete related documentation; palletize shipments and operate forklift as needed.
• Perform basic facilities tasks such as changing HVAC filters and lighting.

Skills

PPE compliance

GMP knowledge

Batch records

SOP adherence

Equipment operation

Forklift operation

Data integrity

Education

High School Diploma/GED

Tools

Forklift

Clean room equipment

Job description

Shift: M-F 7:30am-4:00pm Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. This is a full-time, onsite, Facilities Technician/GMP Manufacturing Technician II position located in Norristown, PA, Monday - Friday, from 6:30 a.m. to 3:00 p.m. OR 7:30 a.m. to 4:00 p.m. Compensation: $24.00 - $38.00 per hour The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate’s geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer. Make an Impact. Build a Career. Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

SUMMARY

Responsible for dispensing, manufacturing, and packaging operations in a Current Good Manufacturing Practice (cGMP) environment, while wearing appropriate PPE, maintaining accurate batch records and following all Standard Operating Procedures (SOPs). General, routine cleaning and maintenance of all equipment and instrumentation. Will also include general facility maintenance, shipping, receiving, and material handling.

ESSENTIAL FUNCTIONS

• Assist with dispensing, manufacturing, and packaging of GMP materials, while wearing appropriate PPE, as required.
• Complete manufacturing batch records in accordance with GMP documentation requirements.
• Perform assigned tasks in a clean room, including cleaning equipment, instrumentation and manufacturing suites.
• Maintain accurate records to support data integrity.
• Adhere to all SOPs, cGMP's and applicable FDA regulations.
• Accept shipments of raw materials; complete documentation for receipt Palletize shipments, complete shipping paperwork, drive fork lift to load trucks
• Complete basic facilities tasks; change HVAC filters, lights, etc.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS

Education and Experience

High School Diploma/GED required, some college or technical training preferred. One (1) year of manufacturing operations or technical experience preferred; OR an equivalent combination of education, training and experience.

Required Knowledge and Skills

Required Knowledge

Prior knowledge preferred, or ability to be trained, in the use of drug product manufacturing equipment and instrumentation. Fundamental knowledge of practices, and techniques to troubleshoot and solve problems. Conscientious, follows directions, willing to learn. Fundamental understanding of working with batch records and documenting in laboratory notebooks preferred. Effective methods to communicate with staff, coworkers, and customers to ensure safe, effective and appropriate operations. Correct business English, including spelling, grammar, and punctuation.

Required Skills

Ability to operate manufacturing equipment; while wearing appropriate PPE as required. Ability to follow standard operating procedures. Mechanical and math skills. Ability to operate in both a team and individual contributor environment. Fundamental understanding and following applicable laws, codes and regulations. Contributing effectively and taking initiative in accomplishing team or work unit goals, objectives, and activities. Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of work.

PHYSICAL/MENTAL REQUIREMENTS

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 50 pounds of force occasionally and/or up to 40 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

WORKING ENVIRONMENT

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.

Benefits

When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Pace® makes the world a safer, healthier place. We partner with clients to provide the service, science, and laboratory data needed to make critical decisions that benefit us all. Through a nationwide laboratory network, Pace® advances the science of businesses, industries, consulting firms, government agencies, and others. More at PACELABS.com.