Department

Production

Reports To 

Cleanroom Supervisor

Starting Pay

$20 per hour

Major Responsibilities

• Handling and processing of product in the cleanroom.

• Follow written instructions and procedures to process product.

• Sanitize cleanroom equipment.

• Follow proper garmenting procedures.

• Follow proper documentation.

• Maintain the cleanliness of immediate work areas.

• Inspect product for defects and document irregularities.

• Effectively communicate with management.

• Adhere to cleanroom policies and standards.

• Follow health and safety guidelines.

• Other duties as assigned.

Qualifications

• High School Diploma.

• Requires attention to detail.

• Good problem-solving skills.

• Good oral and written communication skills.

• Ability to lift up to 20 lbs. consistently.

• May require mandatory overtime as necessary.

• Ability to stand on feet for extended periods of time.

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Department

Facilities

Reports To 

Facilities Manager

Starting Pay

$17 per hour

Major Responsibilities

• Service, clean, and supply restrooms.

• Clean building floors by sweeping, mopping, scrubbing, or vacuuming.

• Gather and empty trash.

• Follow procedures for the use of chemical cleaners and power equipment to prevent damage.

• Mix water and detergents or acids in containers to prepare cleaning solutions, according to specifications.

• Clean windows, glass partitions, or mirrors, using soapy water or other cleaners, sponges, or squeegees.

• Notify managers concerning the need for major repairs or additions to building operating systems.

• Dust furniture, walls, machines, or equipment.

• Strip, seal, finish, and polish floors.

• Clean and polish furniture and fixtures.

• Groundskeeping work as needed.

• Remove snow from sidewalks, driveways, or parking areas, using snowplows, snow blowers, or snow shovels, or spread snow-melting chemicals.

• Set up, arrange, or remove decorations, tables, chairs, ladders, or scaffolding to prepare facilities for events, such as banquets or meetings.

• Follow Cleaning Facility Checklist.

• Fills out janitorial checklists at the end of every shift.

• Follows safety rules and precautions.

• Adheres to company policies and procedures.

• Other duties as assigned.

Qualifications

• High School Diploma.

• Requires attention to detail.

• Ability to lift up to 30 lbs.

• Ability to use hand tools such as hand carts, etc.

• Ability to read and understand instructions.

• May require mandatory overtime as necessary.

• Ability to stand on feet for an extended period of time.

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Department

Facilities

Reports To 

Equipment Manager

Starting Pay

$55,000 per year

Major Responsibilities

• Maintain or repairs specialized equipment or machinery located in the cleanroom.

• Records and reports damaged, worn, or broken parts.

• Repairs broken machines quickly and efficiently.

• Prepares reports documenting work performed.

• Perform annual qualification and calibration of cleanroom equipment.

• Coordinates with managers to schedule regular maintenance on machines.

• Maintain supplies and inventory of parts for equipment.

• Other duties as assigned by the Facilities Manager.

Qualifications

• Basic knowledge of electrical and mechanical systems.

• Ability to read and understand technical manuals and drawings.

• Able to bend, stretch, push, pull, and move as needed to reach, clean, and service
  equipment.

• Be able to stand for long periods of time.

• Ability to lift and carry up to 50 pounds.

• Must be able to visually inspect the equipment.

• Must have good hearing for operating tools or safely performing physical work.

• Communicate clearly and effectively with workers and other professionals.

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Department

Facilities

Reports To 

Facilities Manager

Starting Pay

$20 per hour

Major Responsibilities

Construction & Maintenance

• Paint or repair roofs, windows, doors, floors, woodwork, drywall, or other parts of building structures.
• Repair machines, equipment, or structures, using tools such as hammers, hoists, saws, drills, wrenches, or equipment such as precision measuring instruments or electrical or electronic testing devices.
• Maintain or repair specialized equipment or machinery located in cafeterias, laundries, hospitals, stores, offices, or factories.
• Records and reports damaged, worn, or broken parts.
• Assemble, install, or repair wiring, electrical or electronic components, pipe systems, plumbing, machinery, or equipment.
• Installation of appliances and other various types of equipment.
• Repairs broken machines quickly and efficiently.
• Prepares reports documenting work performed.
• Cleans, organizes, inventories, stocks, and otherwise maintains shop areas, parts, tools, and supplies.
• Coordinates with managers to schedule regular maintenance on machines.
• Set up and operate machine tools to repair or fabricate machine parts, jigs, fixtures, or tools.
• Provide grounds keeping services, such as landscaping and snow removal.
• Fabricate or repair counters, benches, partitions, or other wooden structures, such as sheds or outbuildings.
• Ability to cut, grind and weld metals.
• Ability to be on call as needed for facility maintenance and emergency repairs.

Other

• Perform cleaning services activities such as dusting, mopping, and sweeping when needed.
• Basic computer knowledge in MS word and excel programs.
• Other duties as assigned, by various departments.

Qualifications

• High school Diploma or equivalent.
• Basic knowledge of HVAC, plumbing, and electrical systems.
• Basic knowledge of wood and steel framing practices.
• Ability to read technical manuals and drawings.
• Able to bend, stretch, push, pull, and move as needed to reach, clean, and service machinery.
• Be able to stand for long periods of time.
• Be able to work from elevated areas such as ladders, manlifts and mezzanines.
• Ability to lift and carry up to 50 pounds.
• Must be able to visually inspect machinery and facility.
• Must have good hearing for operating tools or safely performing physical work.
• Communicate clearly and effectively with workers and other professionals within the organization.

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Department

Quality

Reports To 

Quality Manager

Starting Pay

$55,000 per year

Major Responsibilities

• Ensures Cleanroom B personnel have the proper training before executing any task.
• Ensures Cleanroom B area has adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination.
• Ensures cleanroom B process follows the proper flow of components, drug product containers, closures, labeling, in-process materials, and drug products throughout the building.
• Ensures the receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
• Ensures proper manufacturing and processing, Packaging and labeling operations; Quarantine storage before the release of drug products;
• Ensures all equipment in Cleanroom B is identified and has the required Calibration dates.
• Ensures Aseptic processing, which includes as appropriate:
  a) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; report any observation to the production and quality department.
  b) Temperature and humidity controls are as appropriate.
• Review Formula Card for proper Verification of startup products vs. WO
• Water resistivity before starting the washing procedure.
• TOC testing of water.
• Cleanliness Check of Perforated Stainless Steel cleaning Baskets, Cover baskets, Cover trays, and Cookie trays.
• Clearance of Loading Area Check, Loading Table and surrounding to be Free of products and Clean.
• Drying / Depyrogenation- Oven Cycle Temperature Ticket Check.
• Clearance of Intimate packaging process:
  a) items vs. MO/WO (Spacer, Bag size, bracket, vials, etc..) And
  b) cleanliness check of the Parts such as Cover Baskets, Tweezers, a special tool (check instruction)
  c) Table Clean and Clear of previous WO
• Perform inspection of any Quantity sufficient (QS) for Vials or missing items.
• Checks Sealers Temperature setting.
• Checks Autoclave Cleanliness and clearance.
• Ensures the Verification of information on autoclave strips for each work order is filled in and completed.
• Checks Autoclave sterility sticker colors.
• Verifies Omega Meter temperature data.
• Verifies correct labeling of the Items on the carts.
• Performs Line clearance before double bagging.
• Checks and verifies the actual yields and percentages of theoretical yield calculations after each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.
• Reports any deviation.
• Reports any Non-conformances.
• Handles the workflow of any Rework or Reprocessing work.
• Verifies the double-bagging area and products on the line.

Qualifications

• Be able to comprehend Acorn’s environment of fast production and the need for Urgency in getting things done without compromising the quality of the product.
• B.S in Physical Science.
• Requires attention to detail.
• Good problem-solving skills.
• Good oral and written communication skills.
• Ability to lift up to 20 lbs. consistently.
• Ability to work standing for long periods of time.
• Able to use office machinery (printers, scanners, etc.)
• Microsoft Office suite (Excel, Word, Outlook, PowerPoint, Access)

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Department

Quality

Reports To 

Quality Manager

Starting Pay

$85,000 per year

Description

This Role ensures that equipment, systems, and processes comply with regulatory and quality standards in industries such as pharmaceuticals, biotechnology, and medical devices. They develop and execute validation protocols (IQ, OQ, PQ), conduct process and cleaning validation, troubleshoot deviations, and maintain detailed documentation to meet compliance requirements (FDA, EMA, GMP, ISO). This role is critical for ensuring product safety, consistency, and regulatory approval.

Major Responsibilities

Validation and Qualification Management

• Develop, review, and maintain Validation Protocols and the Validation Master Plan to ensure alignment with GMP and regulatory requirements.
• Oversee the Validation Program, including tracking and maintaining the Validation Master List.
• Establish documented evidence to provide a high degree of assurance that processes, systems, and equipment consistently produce products that meet specifications and quality attributes.
• Perform qualification and validation activities for Facilities, Critical process equipment, Lab instruments, and Utilities (e.g., WFI systems, HVAC, compressed air, cleanrooms).
• Execute and maintain cleaning validation programs, ensuring that cleaning procedures effectively remove contaminants to prevent cross-contamination.
• Conduct validation for manufacturing processes, aseptic techniques, sterilization processes, and computer systems (CSV), ensuring compliance with 21 CFR Part 11.
• Support Annual Product Reviews (APR) and Periodic Reviews by gathering and analyzing validation data.

Documentation and Protocols

• Develop and execute IQ, OQ, PQ protocols and reports in compliance with GMP, FDA, ISO 13485, and 21 CFR Parts 210, 211, 820.
• Maintain validation documentation, including Calibration records, User requirements specifications (URS), Risk assessment documentation (FMEA, HACCP, etc.), Equipment and process criticality analysis, Utility qualification and commissioning reports, Cleaning validation protocols and reports, Protocol execution records and deviations, Validation summary reports (VSR), Change control documentation for requalification assessments.
• Implement Good Documentation Practices (GDP) to ensure audit readiness.

Risk Assessment and Quality Assurance

• Conduct risk assessments for validation processes and determine critical process parameters (CPPs) and critical quality attributes (CQAs).
• Ensure validation activities follow ICH Q9, ICH Q10, and ICH Q7 principles.
• Perform gap assessments and remediation plans for validation-related non-conformances.
• Identify and execute requalification/revalidation activities triggered by changes in process, equipment, or regulatory updates.

Sampling and Testing

• Establish and execute sampling plans for cleaning validation, process validation, and media fill simulations in a GMP-controlled environment.
• Collect and submit samples for microbiological and chemical testing, ensuring proper handling and documentation.
• Verify the calibration of analytical and test instruments before and after testing to maintain accuracy.
• Collaborate with microbiology and analytical labs for method validation and swab recovery studies.

Communication and Collaboration

• Coordinate validation activities with Production, Engineering, R&D, Microbiology, and Quality Assurance (QA) teams.
• Ensure cross-functional alignment on process validation, method validation, and cleaning validation requirements.
• Route validation documentation for approvals and ensure timely execution and completion.
• Participate in Regulatory Inspections and Internal Audits, ensuring audit readiness for validation processes.

Statistical and Analytical Tools

• Utilize DOE (Design of Experiments), Process Capability Analysis, and Control Charts to evaluate validation data.
• Use statistical tools (Excel-based data analysis tools) to analyze and interpret process validation results.
• Develop process flow diagrams, FMEAs, and validation roadmaps to improve validation project efficiency.

Internal Audits and Compliance

• Assist in internal audits, regulatory audits, and supplier audits, ensuring validation documentation meets compliance standards.
• Follow GMP, GDP, and regulatory guidance as per FDA, EMA, WHO, and PIC/S requirements.
• Ensure continuous improvement initiatives in validation practices to maintain compliance with evolving industry standards.

Training and SOP Development

• Train personnel on validation protocols, SOPs, and execution procedures.
• Assist in developing and revising Standard Operating Procedures (SOPs) related to validation, qualification, and cleaning procedures.
• Ensure all personnel involved in validation activities understand and adhere to regulatory requirements.

Skills

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Access).
• Expertise in creating and maintaining validation protocols, reports, and regulatory documentation.
• Familiarity with statistical tools for data analysis in validation studies.
• Strong knowledge of GMP, FDA, EMA, ISO 13485, and USP requirements for validation and qualification.
• In-depth understanding of risk-based validation approaches (ICH Q9, ICH Q10).
• Experience with sterilization validation (steam), cleaning validation, and process validation.
• Knowledge of critical cleaning parameters (e.g., detergent selection, residue limits, swab recovery, rinse sampling, TOC testing).
• Strong problem-solving and deviation/investigation resolution skills for validation-related issues.
• Ability to lift up to 20 lbs. for handling validation equipment and materials.
• Capable of standing for extended periods in a cleanroom or laboratory setting.
• Ability to focus for long periods during document review, validation execution, and data analysis.
• Strong written and verbal communication skills for authoring protocols, reports, and presenting validation findings.
• Ability to effectively coordinate with cross-functional teams, including Production, Quality Assurance, R&D, and Engineering.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field (required).
• Relevant certifications (Six Sigma, GMP Training, Validation Specialist Certification) are a plus.
• 3+ years of experience in validation and qualification in a GMP-regulated industry (pharmaceuticals, biotechnology, medical devices, or sterile manufacturing).
• Strong background in IQ, OQ, PQ, Cleaning Validation, and Process Validation.
• Experience working in FDA, EMA, ISO 13485, and 21 CFR Part 210/211/820 regulated environments.
• Hands-on experience with validation execution, deviations, CAPAs, and change control processes.

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