Drug Product Principal Process Engineer Job at PCI Pharma Services (Bedford)

Principal, Packaging Engineering

Lead all aspects of packaging process development, qualification, validation, la...

Location

United States

Salary:

180000.00 - 240000.00 USD / Year

Loyal

Expiration Date

Until further notice

Requirements

Bachelor’s, Master’s, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field
10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, with significant experience supporting commercial or late-stage OSD products
Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container–closure systems
Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ)
Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations
Experience supporting commercial packaging operations, including launch readiness and ongoing supply
Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to packaging-related regulatory questions
Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards
Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements
Experience supporting or participating in pre-approval inspections (PAIs) related to packaging

Job Responsibility

Lead packaging process development, scale-up, and optimization for OSD drug products
Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations
Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements
Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness
Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs
Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity
Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries
Support or participate in PAIs and other regulatory interactions related to packaging
Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations
Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs

What we offer

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

Fulltime

Principal Packaging Engineer- Drug Product Design & Development

We are seeking an accomplished and forward-thinking leader to join our Biotherap...

Location

United States , St. Louis - Chesterfield; Andover

Salary:

106000.00 - 171500.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or Science (Packaging, Mechanical, Materials, Biomedical, Chemical, Chemistry, Biochemistry, or related) with 12+ years of relevant experience
OR Master’s/MBA with 10+ years of experience
OR PhD with 8+ years of experience in pharmaceutical packaging development
Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, Computrac, plunger movement chambers)
Experience in GMP and/or ISO 13485 environments
In-depth understanding of global regulatory and quality standards (FDA, ICH, ISO 13485, 11040, 10993, USP/EP/JP compendia, combination product regulations)
Ability to interface with regulatory agencies and provide sound technical justifications
Demonstrated success leading teams and cross-functional initiatives
Excellent written, verbal, and presentation skills
Strong project management and stakeholder engagement capabilities

Job Responsibility

Provide strategic direction and day-to-day leadership for laboratory operations supporting drug product and combination product development
Mentor, develop, and empower a high-performing team
Contribute to goal setting, performance reviews, and career development for packaging engineers
Act as the subject matter expert for laboratory operations, ensuring compliance with ISO 13485, GMP, and internal quality systems
Own equipment calibration and qualification activities
Ensure laboratory notebooks and electronic lab notebook (eLN) systems meet procedural, regulatory, and best-practice standards
Oversee and review testing activities, protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products
Lead component and container closure system selection, qualification, and development activities
Author and support regulatory submission content and respond to packaging-related regulatory inquiries
Partner closely with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Principal IS Business Analyst – Clinical Study Design and Analysis

Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Desi...

Location

United States

Salary:

143358.00 - 173256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Master’s degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Bachelor’s degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Associate’s degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology
Experience with Agile software development methodologies (Scrum)
Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
Experience in writing requirements for the development of modern web applications
Experience in writing user requirements and acceptance criteria in Agile project management systems such as JIRA

Job Responsibility

Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals
Captures the voice of the customer to define business processes and product needs
Works with Product Managers and customers to define scope and value for new developments
Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog
Ensures non-functional requirements are included and prioritized in the product and release backlogs
Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team
Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog
Translates complex business and technological needs into clear, actionable requirements for development teams
Ensures acceptance criteria and definition of done are well-defined
Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Principal Engineer: Automation - DeltaV

Provide automation technical leadership to a group of Automation Engineers who a...

Location

United States , Holly Springs

Salary:

174409.00 - 202181.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Manufacturing Automation Engineering experience
Associate degree and 10 years of Manufacturing Automation Engineering experience
Bachelor’s degree and 6 years of Manufacturing Automation Engineering experience
Master’s degree and 4 years of Manufacturing Automation Engineering experience
Doctorate degree and 2 years of Manufacturing Automation Engineering experience

Job Responsibility

Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), and Building Management Systems (BMS)
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions
Provide clear documentation for delivered solutions and processes
work closely with QA partners while supporting computerized systems validation processes in a GxP environment
Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines
Provide rotational automation on-call support for manufacturing operations
Maintain detailed specification and engineering policies and procedures that affect multiple organizational units
Assist in the cultivation of a robust talent pipeline with diverse capabilities required to thrive in the present and future based on perception of team needs. Partner with the Sr. Manager and HR to recruit, coach, develop, empower, and retain staff. Ensure an ongoing organizational structure capable of adapting to evolving business needs

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Engineer

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

120354.84 - 149145.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree or foreign equivalent in Mechanical Engineering, Biomedical Engineering or related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the following: Maintain processes for the development, qualification validation and transfer of container closure integrity test methods for product verification, of new products and transfer of knowledge and techniques to partners
21 Code of Federal Regulations CFR Part 11, Good Manufacturing Practices, United States Pharmacopeia USP 697 and United States Pharmacopeia USP 1207
Develop operational procedures and maintenance protocols for various Container Closure Integrity test equipment including vacuum decay, helium leak detection, tracer liquid and high voltage leak detection technologies
Equipment validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
SolidWorks and MS Office Suite
Domain knowledge for Strength of Materials, Material Selection and fluid mechanics

Job Responsibility

Work with team of engineers in the development, validation, qualification and transfer of Title 21 of the Code of Federal Regulations (CFR) Part 11 compliant physical test methods for Container Closure Integrity (CCI) of combination products and primary containers
Ensure that primary containers carrying oncology and cardiovascular drug products maintain sterility throughout the container lifecycle, including product filling, transportation, storage, to reach the patients safely
Act as a subject matter expert (SME) regarding Container Closure Integrity Testing to support product filings, qualification of manufacturing processes, and maintenance of routine stability studies
Design, develop, and calibrate fixtures for American Society for Testing and Materials ASTM F2338 compliant vacuum decay testing of vials on Packaging Technologies and Inspection PTI-325 and PTI-440 leak detectors using SolidWorks
Develop, validate and transfer physical test methods for deliverable volume testing of primary containers carrying drug products per United States Pharmacopeia USP 697 and Good Manufacturing Practices (GMP)
Work with industry experts to advance innovative system integrity methods such as Helium Leak Detector, Wilcomat Leak Detector, high voltage leak detection, and other new emerging technologies
Serve as a domain expert for Strength of Materials, Material Selection, fluid mechanics/mass spectrometry, and transport phenomena
Principal author for test method documentation including technical method instructions, operational protocols, equipment qualification, standard operating procedures (SOPs), and technical drawings related to equipment function

What we offer

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program

Fulltime

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

New

Healthcare Assistant & Lead Healthcare Assistant

Are you passionate about supporting older people and making a meaningful differe...

Location

Ireland , Cork

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience in elderly care is desirable but not essential (training may be provided)
QQI Level 5 in Healthcare Support or equivalent is an advantage
A caring, patient and respectful approach to supporting older people
Ability to work flexible shifts including days, nights, and weekends
Strong commitment to resident safety, dignity and wellbeing
Applicants must have legal entitlement to work in Ireland

Job Responsibility

Deliver person-centred care to residents with dignity and respect
Support residents with activities of daily living where required
Encourage independence and social engagement
Maintain a clean, safe and comfortable living environment
Build positive relationships with residents, families, and colleagues
Follow all health, safety and safeguarding procedures
Assist with compliance processes, inspections, and quality standards
Lead Healthcare Assistants will also assist in guiding care teams, supporting best practice, and helping maintain high standards of care delivery

What we offer

Flexible working hours to support work–life balance
Local employment opportunities within the Douglas, Cork area
Competitive rates of pay in line with experience and role
Supportive team environment with ongoing training and development
Employee wellbeing initiatives
Uniform provided
Free on-site parking
Meals provided while on duty

New

Bakery Team Member

Join us to "Change Hospitality For Good". Here at the Cornish Bakery, we want to...

Location

United Kingdom , Falmouth

Salary:

8.05 - 12.80 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Eligible to live and work in the UK

Job Responsibility

Make the World’s Best Coffee
Deliver Outstanding Customer Service
Prepare Award Winning Food
Maintain High standards within the Bakery
Be part of a Team who strive to Aim Higher at all times

What we offer

50% discount on food and drink
Pasty Perks – bespoke reward system offering discounts and savings on favourite brands
Financial well-being benefit through Stream – save directly from wages into a high interest savings account or access wages before pay-day
Employer funded health and wellbeing services with access to a 24/7 GP line, Employee Assistance Program and discounted gym memberships
Paid birthday day off
Member of the shareholder fund (service dependent)
Team social events with in-bakery incentives
Up to 28 days of holiday (including bank holidays), pro rata if necessary

Drug Product Principal Process Engineer

PCI Pharma Services

Location:
United States , Bedford

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 02, 2026

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