This is a high-level management position. Full-Time with 40+ hours a week. Experience is preferred. Interested applicants at minimum must have at least a Bachelor's Degree, or equivalent experience. Preferred candidates will have experience in cGMP-regulated environments, overseeing equipment maintenance coordination, technical compliance investigation handling, and large-scale equipment implementation.
SUMMARY: The Packaging Technical Manager is responsible for packaging equipment reliability, technical systems, and validation support within the Packaging Department. This role oversees equipment maintenance coordination, calibration compliance, technical investigations, capital projects automation initiatives, and packaging technology implementation to support safe, compliant, and efficient manufacturing operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
1. Equipment Maintenance and Operations
· Collaborates with the Packaging Production Manager to ensure packaging equipment are supporting production requirements.
· Oversees inventory and availability of technical spare parts, tooling, and maintenance-related materials required to support packaging operations.
· Ensures packaging equipment and associated measurement systems maintain current calibration status in accordance with GMP requirements.
· Ensure that asset numbers and asset tags are properly affixed and in place on all equipment.
· Maintenance Oversight: Coordinates with engineering for preventative maintenance and emergency repairs.
· Manage technical documentation (e.g., equipment schematics, operation manuals).
2. Equipment & Technology Strategy
- Capital Projects: Leads the selection, purchase, and installation of new packaging machinery (e.g., high-speed bottling, blister lines, or serialization equipment). Support the Company and management in the selection, procurement, installation, commissioning, validation, and practical application of new equipment; assist in drafting relevant SOPs (Standard Operating Procedures).
- Technology Roadmap: Aligns the packaging capabilities with future company needs, such as implementing sustainable packaging or advanced robotics.
- Automation & Robotics: Acts as the subject matter expert (SME) for digital systems, including serialization (track-and-trace) and vision inspection systems. Support the company and management initiatives to adopt automation, robotics, and AI technologies. Evaluates and supports automation, robotics, serialization, vision inspection, and digital manufacturing technologies to improve equipment reliability, process efficiency, and operational performance.
3. Validation & Quality Engineering Coordination
- Equipment Qualification: Coordinate IQ/OQ/PQ (Installation, Operational, and Performance Qualification) to ensure every machine operates within FDA-mandated specifications.
- Technical Investigations: Leads "root cause" analysis for complex mechanical or process failures that simple troubleshooting can't solve.
- Assist the QA Department and the Production Manager in the investigation of NCRs (Non-Conformance Reports) and CAPAs (Corrective and Preventive Actions), ensuring the effective implementation of corrective measures.
- Assist the Engineering Department with equipment parameter configuration and software application deployment, in collaboration with QA requirements and quality system controls.
4. New Packaging Design & Development
- New Product Introduction (NPI): Coordinates the "technical transfer" of new drugs from development to commercial packaging lines.
- Material Science: Coordinates new packaging materials (foils, plastics, glass) for compatibility with drug stability and shelf life. Assist the R&D Department in new product development, including the research of new packaging materials, and lead the production-oriented development and implementation of packaging technologies for new products.
SUPERVISORY RESPONSIBILITIES: Manages subordinate supervisors in the Packaging department. Is responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.
Compliance with governmental agencies is required.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: Bachelor’s degree or equivalent; or eight to ten years related experience and/or training; or equivalent combination of education and experience.
LANGUAGE SKILLS: Ability to read and interpret technical drawing and blueprints, documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of the organization.
MATHEMATICAL SKILLS: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, volume, and efficiency.
REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL DEMANDS: The physical demands described here are representative of those required of an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to talk or hear. The employee is occasionally required to stand, walk, sit, reach with hands and arms, and stoop, kneel, crouch, or crawl.
The employee must occasionally lift and/or move up to 25 pounds.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee frequently works near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles.
The noise level in the work environment is usually moderate.
Sunshine Act
Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.
EEO & Employment Eligibility
Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer.
Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Work Remotely
Job Type: Full-time
Pay: $95,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
Work Location: In person
